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Colecistectomía de incisión pequeña versus colecistectomía abierta para pacientes con colecistolitiasis sintomática

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Referencias

Referencias de los estudios incluidos en esta revisión

Assalia 1993 {published data only}

Assalia A, Schein M, Kopelman D, Hashmonai M. Minicholecystectomy vs conventional cholecystectomy ‐ a prospective randomized trial ‐ implications in the laparoscopic era. World Journal of Surgery 1993;17(6):755‐9.

Coelho 1992a {published data only}

Coelho JC, Campos GM, Matias JE. Cholecystectomy through mini‐incision and through classic subcostal incision: a prospective randomized study [Colecistectomia por mini‐incisao subcostal classica: estudo prospectivo randomizado]. Revista Brasileira de Cirurgia 1992;82:67‐9.

Coelho 1993 {published data only}

Coelho JCU, DeAraujo RPM, Marchesini JB, Coelho ICMM, DeAraujo LRR. Pulmonary‐function after cholecystectomy performed through Kocher incision, a mini‐incision, and laparoscopy. World Journal of Surgery 1993;17(4):544‐6.

O'Dwyer 1992 {published data only}

O'Dwyer PJ, McGregor JR, McDermott EWM, Murphy JJ, O'Higgins NJ. Patient recovery following cholecystectomy through a 6‐cm or 15‐cm transverse subcostal incision ‐ a prospective randomized clinical trial. Postgraduate Medical Journal 1992;68(804):817‐9.

Schmitz 1997 {published data only}

Schmitz R, Rohde V, Treckmann J, Shah S. Randomized clinical trial of conventional cholecystectomy versus minicholecystectomy. British Journal of Surgery 1997;84(12):1683‐6.

Seenu 1994 {published data only}

Seenu V, Misra MC. Mini‐lap cholecystectomy ‐ an attractive alternative to conventional cholecystectomy. Tropical Gatroenterology 1994;15(1):29‐31.

Wani 2002 {published data only}

Wani KA, Dar HA, Malik AA, Chowdry NA. Comparison of postoperative pulmonary function tests after cholecystectomy performed through Kocher's incision and mini‐incision. International Surgery 2002;87(2):94‐8.
Wani KA, Malik AA, Noor UD, Wani NA, Chowdhry N. Minicholecystectomy vs conventional cholecystectomy: a prospective study. Implications in the laparoscopic era. JK Practitioner 2000;7:30‐3.

Referencias de los estudios excluidos de esta revisión

Agnifili 1993 {published data only}

Agnifili A, Guadagni S, Ibi I, Verzaro R, Gola P, Gianfelice F, et al. Pulmonary function after laparoscopic and open cholecystectomy [abstract]. British Journal of Surgery 1993;80(Suppl):S44.
Agnifili A, Ibi I, Guadagni S, Verzaro R, Gianfelice F, Mancini E, et al. Perioperative pain and stress: a comparison between video laparoscopic cholecystectomy and "open" cholecystectomy [Dolore e stress perioperatori: confronto tra videolaparocolecistectomia e colecistectomia 'open']. Il Giornale di Chirurgia 1993;14(7):344‐8.
Agnifili A, Verzaro R, Colangeli A, Debernardinis G, Ibi I. Perioperative pulmonary‐function, pain and stress‐response after cholecystectomy performed via laparotomy or laparoscopy ‐ comparison between laparoscopy and laparotomy. Minimally Invasive Therapy & Allied Technologies 1993;2(6):283‐8.
Ibi I, Agnifili A, Verzaro R, Carducci G, Marino M, Mancini E, et al. Respiratory function, postoperative pain and stress following videolaparocholecystectomy and traditional cholecystectomy [Funzione respiratoria, dolore e stress perioperatori dopo videolaparocolecistectomia e colecistectomia tradizionale]. Chirurgia 1994;7:97‐102.

Al Tameem 1995 {published data only}

Al Tameem M. Mini‐laparotomy cholecystectomy: splitting versus partial and whole transection of the rectus abdominis muscle. Saudi Medical Journal 1995;16(2):113‐5.

Alexander 1997 {published data only}

Alexander JI. Pain after laparoscopy. British Journal of Anaesthesia 1997;79(3):369‐78.

Allen 2002 {published data only}

Allen JW, Polk HC. A study of added costs of laparoscopic cholecystectomy based on surgery preference cards. American Surgeon 2002;68(5):474‐6.

Alponat 2002 {published data only}

Alponat A, Cubukcu A, Gonullu N, Canturk Z, Ozbay O. Is minisite cholecystectomy less traumatic? Prospective randomized study comparing minisite and conventional laparoscopic cholecystectomies. World Journal of Surgery 2002;26(12):1437‐40.

Anonymous 1995 {published data only}

Disposables targeted to reduce lap chole cost. OR Manager 1995;11(11):14.

Assalia 1997 {published data only}

Assalia A, Kopelman D, Hashmonai M. Emergency minilaparotomy cholecystectomy for acute cholecystitis: prospective randomized trial‐‐implications for the laparoscopic era. World Journal of Surgery 1997;21(5):534‐9.

Bablekos 2003 {published data only}

Bablekos GD, Roussou T, Rasmussen T, Vassiliou MP, Behrakis PK. Postoperative changes on pulmonary function after laparoscopic and open cholecystectomy. Hepato‐Gastroenterology 2003;50(53):1193‐200.

Barkun 1992 {published data only}

Barkun JS, Barkun AN, Sampalis JS, Fried G, Taylor B, Wexler MJ, et al. Randomized controlled trial of laparoscopic versus mini cholecystectomy. Lancet 1992;340(7):1116‐9.
Barkun JS, Caro JJ, Barkun AN, Trindade E. Cost‐effectiveness of laparoscopic and mini‐cholecystectomy in a prospective randomized trial. Surgical Endoscopy 1995;9(11):1221‐4.

Barkun 1993 {published data only}

Barkun JS, Barkun AN, Meakins JL, Bailar J, Battista RN, Brassard R, et al. Laparoscopic versus open cholecystectomy ‐ the Canadian experience. American Journal of Surgery 1993;165(4):455‐8.

Baxter 1992 {published data only}

Baxter JN, O'Dwyer PJ. Laparoscopic or minilaparotomy cholecystectomy?. BMJ (Clinical Research Ed.) 1992;304(6826):559‐60.

Bellon 1998 {published data only}

Bellon JM, Manzano L, Bernardos L, Ga Honduvilla N, Larrad A, Bujan J, et al. Cytokine levels after open and laparoscopic cholecystectomy. European Surgical Research 1997;29(1):27‐34.
Bellon JM, Manzano L, Larrad A, Honduvilla GN, Bujan J, Alvarez‐Mon M. Endocrine and immune response to injury after open and laparoscopic cholecystectomy. International Surgery 1998;83(1):24‐7.

Berggren 1994 {published data only}

Berggren U, Gordh T, Grama D, Haglund U, Rastad J, Arvidsson D. Laparoscopic versus open cholecystectomy ‐ hospitalization, sick leave, analgesia and trauma responses. British Journal of Surgery 1994;81(9):1362‐5.

Bernard 1994 {published data only}

Bernard A, Aho S, Charvet‐Protat S, Durieux P. Evaluation of laparoscopy in intestinal surgery and gynecological surgery and its economic implications (Three reports). Paris: Agence Nationale pour le Developpement de l'Evaluation Medicale (ANAES)1994.

Bigard 1995 {published data only}

Bigard MA, Bernard A, Cassan P, Deplantez J, Fagniez PL, Fortier B, et al. Indications and methods of cholecystectomy in treatment of gallstones [Indications et modalites de la cholecystectomie dans la lithiase vesiculaire]. Gastroenterologie Clinique et Biologique 1995;19(8‐9):707‐17.

Blanc‐Louvry 2000 {published data only}

Blanc‐Louvry I, Coquerel A, Koning E, Maillot C, Ducrotte P. Operative stress response is reduced after laparoscopic compared to open cholecystectomy ‐ The relationship with postoperative pain and ileus. Digestive Diseases and Sciences 2000;45(9):1703‐13.

Blomstedt 1972 {published data only}

Blomstedt B, Welin‐Berger T. Incisional hernias. A comparison between midline, oblique and transrectal incisions. Acta Chirurgica Scandinavica 1972;138(3):275‐8.

Bolke 2000 {published data only}

Bolke E, Jehle PM, Nothnagel B, Seidelmann M, Storck M, Orth K. A prospective randomised study on endotoxaemia, mediator release and morbidity in conventional, compared with laparoscopic cholecystectomy. Minimally Invasive Therapy & Allied Technologies 2000;9(6):387‐92.

Bruce 1999 {published data only}

Bruce DM, Smith M, Walker CBJ, Heys SD, Binnie NR, Gough DB, et al. Minimal access surgery for cholelithiasis induces an attenuated acute phase response. American Journal of Surgery 1999;178(3):232‐4.
Walker CB, Bruce DM, Heys SD, Gough DB, Binnie NR, Eremin O. Minimal modulation of lymphocyte and natural killer cell subsets following minimal access surgery. American Journal of Surgery 1999;177(1):48‐54.

Bukan 2004 {published data only}

Bukan MH, Bukan N, Kaymakcioglu N, Tufan T. Effects of open vs. laparoscopic cholecystectomy on oxidative stress. Tohoku Journal of Experimental Medicine 2004;202(1):51‐6.

Byrne 1994 {published data only}

Byrne J, Timon D, Armstrong C, Horgan PG, Quill DS. A comparison of analgesic requirements and pulmonary‐function in open versus laparoscopic cholecystectomy. Minimally Invasive Therapy & Allied Technologies 1994;3(1):3‐6.

Calland 2001 {published data only}

Calland JF, Tanaka K, Foley E, Bovbjerg VE, Markey DW, Blome S, et al. Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Annals of Surgery 2001;233(5):704‐15.

Caplan 1999 {published data only}

Caplan G, Board N, Paten A, Tazelaar MJ, Crowe P, Yap SJ, et al. Decreasing lengths of stay: the cost to the community. Australian and New Zealand Journal of Surgery 1999;69(6):433‐7.

Champault 2002 {published data only}

Champault A, Vons C, Dagher I, Amerlinck S, Franco D. Low‐cost laparoscopic cholecystectomy. British Journal of Surgery 2002;89(12):1602‐7.

Charlo 1995 {published data only}

Charlo DT, Fernandez MM, Tejido SC. A cost analysis of laparoscopic cholecystectomy compared with the open technic [Analisis de costes de la colecistectomia laparoscopica en comparacion con la abierta]. Revista Espanola de Enfermedades Digestivas 1995;87(6):449‐52.

Chaudhary 1999 {published data only}

Chaudhary D, Verma GR, Gupta R, Bose SM, Ganguly NK. Comparative evaluation of the inflammatory mediators in patients undergoing laparoscopic versus conventional cholecystectomy. Australian and New Zealand Journal of Surgery 1999;69(5):369‐72.

Chumillas 1998 {published data only}

Chumillas MS, Ponce JL, Delgado F, Viciano V. Pulmonary function and complications after laparoscopic cholecystectomy. European Journal of Surgery 1998;164(6):433‐7.

Clezy 1996 {published data only}

Clezy JKA. Randomized trial of laparoscopic cholecystectomy and mini‐cholecystectomy [letter]. British Journal of Surgery 1996;83(2):279.

Coelho 1992 {published data only}

Coelho JC, Marchesini JB, Campos AC, Camargo CA, Griilo MA, Campos GM. Cholecystectomy through mini‐laparotomy [Colecistectomia por mini‐laparotomia]. Revista Brasileira de Cirurgia 1992;19:213‐5.

Coskun 2000 {published data only}

Coskun I, Hatipoglu AR, Topaloglu A, Yoruk Y, Yalcinkaya S, Caglar T. Laparoscopic versus open cholecystectomy: effect on pulmonary function tests. Hepato‐Gastroenterology 2000;47(32):341‐2.

Da Costa 1995 {published data only}

Da Costa ML, Qureshi MA, Brindley NM, Burke PE, Grace PA, Bouchier‐Hayes D. Normal inspiratory muscle strength is restored more rapidly after laparoscopic cholecystectomy. Annals of the Royal College of Surgeons of England 1995;77:252‐5.

Dauleh 1995 {published data only}

Dauleh MI, Rahman S, Townell NH. Open versus laparoscopic cholecystectomy: a comparison of postoperative temperature. Journal of the Royal College of Surgeons of Edinburgh 1995;40(2):116‐8.

Decker 1993 {published data only}

Decker D, Schondorf M, Decker P, Bidlingmaier F, Hirner A, von Rucker A. Evaluation of tissue trauma with the help of activation markers on the cell membrane of leukocytes. A comparison: laparoscopic versus convertional cholecystectomy. Langenbecks Archiv fur Chirurgie 1993;Suppl 1 Forumband:49‐53.

Delogu 1999 {published data only}

Delogu G, Famularo G, Luzzi S, Rubcich P, Giardina A, Masciangelo R, et al. General anesthesia mode does not influence endocrine or immunologic profile after open or laparoscopic cholecystectomy. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 1999;9(5):326‐32.

Demirer 2000 {published data only}

Demirer S, Karadayi K, Simsek S, Erverdi N, Bumin C. Comparison of postoperative acute‐phase reactants in patients who underwent laparoscopic v open cholecystectomy: a randomized study. Journal of Laparoendoscopic & Advanced Surgical Techniques ‐ Part A 2000;10(5):249‐52.

Dionigi 1994 {published data only}

Dionigi R, Dominioni L, Benevento A, Giudice G, Cuffari S, Bordone N, et al. Effects of surgical trauma of laparoscopic vs open cholecystectomy. Hepato‐Gastroenterology 1994;41(5):471‐6.
Dominioni L, Benevento A, Carcano G, Chiappa A, Dionigi R. Acute‐phase response after laparoscopic and open cholecystectomy [abstract]. British Journal of Surgery 1993;80:S44.

Dohrmann 1993 {published data only}

Dohrmann A, Richthammer M, Jochims J, Stremmel W. Postoperative changes in pulmonary function after laparoscopic versus conventional cholecystectomy ‐ a prospective study [Postoperative Veranderungen der Lungenfunktion nach Laparoskopischer versus konventioneller Cholezystektomie ‐ eine prospektive Studie]. Minimal Invasive Chirurgie 1993;2(Suppl 1):19‐20.

Eickhoff 1997 {published data only}

Eickhoff H, Milheiro A, Manso LC, Castro‐Sousa F. Alterations in respiratory function after cholecystectomy‐‐open versus laparoscopic cholecystectomy [Veranderungen der Lungenfunktion nach Cholezystektomie ‐ offene versus laparoskopische Cholezystektomie]. Langenbecks Archiv fur Chirurgie, Suppl II (Kongressbericht 1997) 1997;114:1105‐7.

Engin 1998 {published data only}

Engin A, Bozkurt S, Ersoy E, Oguz M, Gokcora N. Stress hyperglycemia in minimally invasive surgery. Surgical Laparoscopy & Endoscopy 1998;8(6):435‐7.

Essen 1995 {published data only}

Essen P, Thorell A, McNurlan MA, Anderson S, Ljungqvist O, Wernerman J, et al. Laparoscopic cholecystectomy does not prevent the postoperative protein catabolic response in muscle. Annals of Surgery 1995;222:36‐42.

Frazee 1991 {published data only}

Frazee RC, Roberts JW, Okeson GC, Symmonds RE, Snyder SK, Hendricks JC, et al. Open versus laparoscopic cholecystectomy. A comparison of postoperative pulmonary function. Annals of Surgery 1991;213:651‐3.

Gal 1997 {published data only}

Gal I, Roth E, Lantos J, Varga G, Jaberansari MT. Inflammatory mediators and surgical trauma regarding laparoscopic access: free radical mediated reactions. Acta Chirurgica Hungarica 1997;36:97‐9.

Galizia 2001 {published data only}

Galizia G, Prizio G, Lieto E, Castellano P, Pelosio L, Imperatore V, et al. Hemodynamic and pulmonary changes during open, carbon dioxide pneumoperitoneum, and abdominal wall‐lifting cholecystectomy ‐ A prospective, randomized study. Surgical Endoscopy 2001;15(5):477‐83.

GarciaCaballero 1993 {published data only}

Garcia‐Caballero M, Vara‐Thorbeck C. The evolution of postoperative ileus after laparoscopic cholecystectomy ‐ a comparative study with conventional cholecystectomy and sympathetic blockade treatment. Surgical Endoscopy 1993;7(5):416‐9.

Glaser 1995 {published data only}

Glaser F, Kuntz C, Klee F, Buhr HJ, Sannwald G, Herfarth C. General stress response to conventional and laparoscopic cholecystectomy. Langenbecks Archiv fur Chirurgie 1993;Suppl 1 Forumband:45‐8.
Glaser F, Sannwald GA, Buhr HJ, Kuntz C, Mayer H, Klee F, et al. General stress response to conventional and laparoscopic cholecystectomy. Annals of Surgery 1995;221(4):372‐80.

Go 1995 {published data only}

Go PMNYH, Stolk MFJ, Obertop H, Dirksen C, van der Elst DH, Ament A, et al. Symptomatic gallbladder stones: cost‐effectiveness of treatment with extracorporeal shock‐wave lithotripsy, conventional and laparoscopic cholecystectomy. Surgical Endoscopy 1995;9(1):37‐41.

Grande 2002 {published data only}

Grande M, Tucci GF, Adorisio O, Barini A, Rulli F, Neri A, et al. Systemic acute‐phase response after laparoscopic and open cholecystectomy. Surgical Endoscopy 2002;16(2):313‐6.

Hagmuller 1997 {published data only}

Hagmuller E, Lorenz D, Gunther HJ, Rumstadt B, Jentschura D. Comparison of catabolic response in muscle after laparoscopic cholecystectomy or conventional cholecystectomy using a 13C‐leucine tracer model [Untersuchungen zum Ausmass der postoperativen Katabolie nach laparoskopischer und konventioneller Cholecystektomie unter Anwendung eines 13C‐leuzin‐tracermodells]. Langenbecks Archiv fur Chirurgie 1997;I Forumband:241‐5.

Hasukic 2002 {published data only}

Hasukic S, Mesic D, Dizdarevic E, Keser D, Hadziselimovic S, Bazardzanovic M. Pulmonary function after laparoscopic and open cholecystectomy. Surgical Endoscopy 2002;16(1):163‐5.

Hauer‐Jensen 1986 {published data only}

Hauer‐Jensen M, Karesen R, Nygaard K, Solheim K, Amlie E, Havig O, et al. Consequences of routine peroperative cholangiography during cholecystectomy for gallstone disease: a prospective, randomized study. World Journal of Surgery 1986;10(6):996‐1002.

Hendolin 2000 {published data only}

Hendolin HI, Paakkonen ME, Alhava EM, Tarvainen R, Kemppinen T, Lahtinen P. Laparoscopic or open cholecystectomy: a prospective randomised trial to compare postoperative pain, pulmonary function, and stress response. European Journal of Surgery 2000;166(5):394‐9.

Hobbs 1995 {published data only}

Hobbs KEF. Laparoscopic cholecystectomy. Gut 1995;36(2):161‐4.

Huang 1996 {published data only}

Huang SM, Wu CW, Lui WY, Peng FK. A prospective randomised study of laparoscopic v. open cholecystectomy in aged patients with cholecystolithiasis. South African Journal of Surgery 1996;34(4):177‐9.

Huguier 1997 {published data only}

Huguier M. Laparoscopic digestive surgery. Hepato‐Gastroenterology 1997;44(13):2‐3.

Hunter 2001 {published data only}

Hunter JG. Clinical trials and the development of laparoscopic surgery. Surgical Endoscopy 2001;15(1):1‐3.

Iwase 1992 {published data only}

Iwase K, Takenaka H, Yagura A, Ishizaka T, Takagaki M, Ohata T, et al. Changes of hemodynamic parameters and urine output during laparoscopic cholecystectomy ‐ compared with mini‐laparotomy cholecystectomy: preliminary report. Nippon Geka Gakkai Zasshi 1992;93(6):663.

Jan 1993 {published data only}

Jan YY, Chen MF. Laparoscopic versus open cholecystectomy: a prospective randomized study. Journal of the Formosan Medical Association 1993;92(Suppl 4):S243‐S249.

Johnson 1997 {published data only}

Johnson A. Laparoscopic surgery. Lancet 1997;349(9052):631‐5.
Johnson A. Laparoscopic surgery ... reproduced by kind permission of the Lancet (Johnson A 1997 Laparoscopic Surgery. Lancet (349) 636‐41). British Journal of Theatre Nursing 1999;9(3):119‐24.

Johnson 1998 {published data only}

Johnson AG. New interventional procedures: efficacy, safety and training. Australian and New Zealand Journal of Surgery 1998;68(1):3‐5.

Johnson 1998a {published data only}

Johnson AG, Majeed AW. Randomized clinical trial of conventional cholecystectomy versus minicholecystectomy [letter]. British Journal of Surgery 1998;85(7):1017‐8.

Karayiannakis 1997 {published data only}

Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Postoperative pulmonary function after laparoscopic and open cholecystectomy. British Journal of Anaesthesia 1996;77(4):448‐52.
Karayiannakis AJ, Makri GG, Mantzioka A, Karousos D, Karatzas G. Systemic stress response after laparoscopic or open cholecystectomy: a randomized trial. British Journal of Surgery 1997;84(4):467‐1.

Karayiannakis 2002 {published data only}

Karayiannakis AJ, Syrigos KN, Savva A, Polychronidis A, Karatzas G, Simopoulos C. Serum E‐cadherin concentrations and their response during laparoscopic and open cholecystectomy. Surgical Endoscopy 2002;16(11):1551‐4.

Kehlet 1993 {published data only}

Kehlet H. Treatment of gallstones ‐ lithotripsy, classical, mini or laparoscopic cholecystectomy? [Behandling af galdeblaeresten ‐ litotripsi, klassisk, mini‐ eller laparoskopisk kolecystektomi?]. Ugeskrift for Laeger 1993;155(11):816‐7.

Keus 2006 {unpublished data only}

Keus E, van Laarhoven CJHM. Small‐incision versus laparoscopic cholecystectomy: blind RCT. Unpublished data.

Kiviluoto 1997 {published data only}

Kiviluoto T, Siren J, Luukkonen P, Kivilaakso E. Laparoscopic vs. open cholecystectomy for acute cholecystitis. A prospective randomized study. Gastroenterology 1997;112(4):A1452.

Kjaersgaard 1994 {published data only}

Kjaersgaard P, Reiertsen O, Trondsen E, Rosseland AR, Larsen S. Comparison of sequential and fixed‐sample designs in a controlled clinical trial with laparoscopic versus conventional cholecystectomy. Scandinavian Journal of Gastroenterology 1994;29(9):854‐8.

Koprulu 1996 {published data only}

Koprulu G, Esen F, Pembeci K, Denkel T. Pulmonary mechanics during laparoscopic surgery. Advances in Experimental Medicine and Biolology 1996;388:643‐6.

Krasinski 1998 {published data only}

Krasinski Z, Gabriel M, Oszkinis G, Dzieciuchowicz L, Begier‐Krasinska B. Thrombophlebitis profunda in patients after conventional and laparoscopic cholecystectomy [Trombophlebitis profunda bei Patienten nach der konventionellen und laparoskopischen Gallenblasenentfernung]. Langenbecks Archiv fur Chirurgie 1998;115(Supp lI Kongressbericht):1105‐6.

Krawczyk 1993 {published data only}

Krawczyk M, Zieniewicz K, Najnigier B, Patkowski W, Nyckowski P. Laparoscopic versus open cholecystectomy [abstract]. British Journal of Surgery 1993;80(Suppl):S46.

Kunz 1992 {published data only}

Kunz R. Laparoscopic versus mini‐lap‐cholecystectomy. Results of a prospective randomized study [Cholezystektomie ‐ laparoskopische versus mini‐lap‐Cholezystektomie. Ergebnisse einer prospektiv randomisierten Studie]. Langenbecks Archiv fur Chirurgie 1993;Suppl Kongressbericht:84‐8.
Kunz R, Berger R, Beger HG. Laparoscopic versus conventional cholecystectomy [Laparoskopische versus konventionelle Cholezystektomie]. Minimal Invasive Chirurgie 1993;2(Suppl 1):2.
Kunz R, Orth K, Vogel J, Steinacker JM, Meitinger A, Bruckner U, et al. Laparoscopic cholecystectomy versus mini‐lap cholecystectomy ‐ results of a prospective randomized study [Laparoskopische Cholecystektomie versus mini‐lap‐Cholecystektomie ‐ Ergebnisse einer prospektiven, randomisierten Studie]. Chirurg 1992;63(4):291‐5.
Schutze F, Osswald C, Berger D, Kunz R, Beger HG. Peri‐ and postoperative mediator release: laparoscopic versus laparotomic cholecystectomy [Peri‐ und postoperative Mediatorenfreisetzung: laparoskopische versus laparotomische Cholecystektomie]. Langenbecks Archiv fur Chirurgie 1993;Suppl 1 Forumband:55‐8.

Kurzawinski 1992 {published data only}

Kurzawinski T, Hayter B, Tate J, Davidson B, Hobbs KEF. The cost implications of laparoscopic vs open cholecystectomy [abstract]. Gut 1992;33:S64.

Lam 1996 {published data only}

Lam CM, Murray FE, Cuschieri A. Increased cholecystectomy rate after the introduction of laparoscopic cholecystectomy in Scotland. Gut 1996;38(2):282‐4.

Lausten 1999 (1) {published data only}

Lausten SB, El Sefi T, Marwan I, Ibrahim TM, Jensen LS, Grofte T, et al. Postoperative hepatic catabolic stress response in patients with cirrhosis and chronic hepatitis. World Journal of Surgery 2000;24(3):365‐71.
Lausten SB, Ibrahim TM, El Sefi T, Jensen LS, Gesser B, Larsen CG, et al. Systemic and cell‐mediated immune response after laparoscopic and open cholecystectomy in patients with chronic liver disease ‐ A randomized, prospective study. Digestive Surgery 1999;16(6):471‐7.

Lausten 1999 (2) {published data only}

Lausten SB, El Sefi T, Marwan I, Ibrahim TM, Jensen LS, Grofte T, et al. Postoperative hepatic catabolic stress response in patients with cirrhosis and chronic hepatitis. World Journal of Surgery 2000;24(3):365‐71.
Lausten SB, Ibrahim TM, El Sefi T, Jensen LS, Gesser B, Larsen CG, et al. Systemic and cell‐mediated immune response after laparoscopic and open cholecystectomy in patients with chronic liver disease ‐ A randomized, prospective study. Digestive Surgery 1999;16(6):471‐7.

Lujan 1998 {published data only}

Lujan JA, Sanchez‐Bueno F, Parrilla P, Robles R, Torralba JA, Gonzalez‐Costea R. Laparoscopic vs. open cholecystectomy in patients aged 65 and older. Surgical Laparoscopy & Endoscopy 1998;8(3):208‐10.

Lukichev 1983 {published data only}

Lukichev OD, Filimonov MI, Zybin IM. A method of laparoscopic cholecystostomy [Metodika laparoskopicheskoi kholetsistostomii]. Khirurgiia 1983;8:125‐7.

Luo 2003 {published data only}

Luo K, Li J, Li L, Wang G, Sun J, Wu S. Operative stress response and energy metabolism after laparoscopic cholecystectomy and open cholecystectomy. Zhonghua Wai Ke Za Zhi [Chinese Journal of Surgery] 2002;40(12):923‐6.
Luo K, Li JS, Li LT, Wang KH, Shun JM. Operative stress response and energy metabolism after laparoscopic cholecystectomy compared to open surgery. World Journal of Gastroenterology 2003;9(4):847‐50.

Majeed 1996 {published data only}

Calvert NW, Troy GP, Johnson AG. Laparoscopic cholecystectomy: a good buy? A cost comparison with small‐incision (mini) cholecystectomy. European Journal of Surgery 2000;166(10):782‐6.
Majeed AW, Troy G, Nicholl JP, Smythe A, Reed MWR, Stoddard CJ, et al. Randomised, prospective, single‐blind comparison of laparoscopic versus small‐incision cholecystectomy. Lancet 1996;347(9007):989‐94.
Squirrell DM, Majeed AW, Troy G, Peacock JE, Nicholl JP, Johnson AG. A randomized, prospective, blinded comparison of postoperative pain, metabolic response, and perceived health after laparoscopic and small incision cholecystectomy. Surgery 1998;123(5):485‐95.

Makinen 1995 {published data only}

Makinen AMH, Nordback IH. Cholecystectomy ‐ comparison of minilaparotomy and laparoscopy. International Surgery 1995;80(2):99‐101.

Malaysian HTA 2005 {published data only}

Malaysian Health Technology Assessment Unit (MHTAU). Minimal access surgery. Kuala Lumpur: Malaysian Health Technology Assessment Unit (MHTAU)2003.

Maruszynski 1995 {published data only}

Maruszynski M, Pojda Z. Interleukin 6 (IL‐6) levels in the monitoring of surgical trauma. A comparison of serum IL‐6 concentrations in patients treated by cholecystectomy via laparotomy or laparoscopy. Surgical Endoscopy 1995;9(8):882‐5.

Matsunaga 1996 {published data only}

Matsunaga MA. Postoperativepain relief and epidural analgesia for open cholecystectomy, laparoscopic cholecystectomy, and gastrectomy. Anesthesia and Resuscitation 1996;32:257‐61.

McGinn 1995 {published data only}

Faux JW, Terzi C, McGinn FP. Prospective randomized trial of mini‐cholecystectomy versus laparoscopic cholecystectomy: a single surgeon study. British Journal of Surgery 1998;85(suppl 1):77.
McGinn FP, Miles AJG, Uglow M, Ozmen M, Terzi C, Humby M. Randomized trial of laparoscopic cholecystectomy and mini‐cholecystectomy. British Journal of Surgery 1995;82(10):1374‐7.

McKellar 1995 {published data only}

McKellar DP, Johnson RM, Dutro JA, Mellinger JB, Peoples JB. Cost‐effectiveness of laparoscopic cholecystectomy. Surgical Endoscopy 1995;9(2):158‐63.

McMahon 1994 {published data only}

McMahon AJ, Baxter JN, Anderson JR, Ramsay G, Galloway D, Russell IT, et al. Assessment of pain after laparoscopic cholecystectomy and minicholecystectomy [abstract]. British Journal of Surgery 1992;79(11):1224.
McMahon AJ, Baxter JN, Anderson JR, Ramsay G, Galloway D, Sunderland G, et al. Pain and pulmonary‐function after laparoscopic and mini‐cholecystectomy ‐ a randomized trial [abstract]. Gastroenterology 1993;104(4):A370.
McMahon AJ, Baxter JN, Anderson JR, Ramsay G, Galloway D, Sunderland G, et al. Postoperative pain and analgesia requirement after laparoscopic and mini‐cholecystectomy ‐ a prospective randomized trial [abstract]. Gut 1992;33(2):S63.
McMahon AJ, Baxter JN, Kenny G, O'Dwyer PJ. Ventilatory and blood‐gas changes during laparoscopic and open cholecystectomy. British Journal of Surgery 1993;80(10):1252‐4.
McMahon AJ, Baxter JN, Kenny G, O'Dwyer PJ. Ventilatory changes during laparoscopic and open cholecystectomy: a randomized trial [abstract]. British Journal of Surgery 1993;80(5):647.
McMahon AJ, O'Dwyer PJ, Cruikshank A, McMillan D, Lowe G, Rumley A, et al. Metabolic changes after laparoscopic and minilaparoscopic cholecystectomy: a randomized trial [abstract]. British Journal of Surgery 1993;80(5):641.
McMahon AJ, O'Dwyer PJ, Cruikshank AM, McMillan DC, O'Reilly DSJ, Lowe GDO, et al. Comparison of metabolic responses to laparoscopic and minilaparotomy cholecystectomy. British Journal of Surgery 1993;80(10):1255‐8.
McMahon AJ, Ross S, Baxter JN, Russell IT, Anderson JR, Morran CG, et al. Symptomatic outcome 1 year after laparoscopic and minilaparotomy cholecystectomy ‐ a randomized trial. British Journal of Surgery 1995;82(10):1378‐82.
McMahon AJ, Ross S, Russell IT, Baxter JN, Anderson JR, Morran C, et al. Return to normal activity after laparoscopic and mini‐cholecystectomy: a randomised trial [abstract]. Gut 1993;34:S68.
McMahon AJ, Ross S, Russell IT, Baxter JN, Anderson JR, Ramsay G, et al. Return to normal activity after laparoscopic and mini‐cholecystectomy ‐ a randomized trial [abstract]. Gastroenterology 1993;104(4):A370.
McMahon AJ, Russell IT, Baxter JN, O'Dwyer PJ. Comparison of the cost of laparoscopic and mini‐cholecystectomy: a randomised trial [abstract]. Gut 1993;34:S68.
McMahon AJ, Russell IT, Baxter JN, Ross S, Anderson JR, Morran CG, et al. Laparoscopic versus minilaparotomy cholecystectomy ‐ a randomized trial. Lancet 1994;343(8890):135‐8.
McMahon AJ, Russell IT, Ramsay G, Sunderland G, Baxter JN, Anderson JR, et al. Laparoscopic and minilaparotomy cholecystectomy ‐ a randomized trial comparing postoperative pain and pulmonary‐function. Surgery 1994;115(5):533‐9.

McMahon 1996 {published data only}

McMahon AJ, O'Dwyer PJ, Baxter JN. Randomised trial of laparoscopic versus small‐incision cholecystectomy [letter]. Lancet 1996;347(9015):1622.

Mealy 1992 {published data only}

Mealy K, Gallagher H. Comparison of the physiological responses to open and laparoscopic cholecystectomy [abstract]. Irish Journal of Medical Science 1992;161:92.
Mealy K, Gallagher H, Barry M, Lennon F, Traynor O, Hyland J. Physiological and metabolic responses to open and laparoscopic cholecystectomy. British Journal of Surgery 1992;79:1061‐4.

Milheiro 1994 {published data only}

Milheiro A, Sousa FC, Manso EC, Leitao F. Metabolic responses to cholecystectomy ‐ open vs laparoscopic approach. Journal of Laparoendoscopic Surgery 1994;4(5):311‐7.

Mimica 2000 {published data only}

Mimica Z, Biocic M, Bacic A, Banovic I, Tocilj J, Radonic V, et al. Laparoscopic and laparotomic cholecystectomy: a randomized trial comparing postoperative respiratory function. Respiration 2000;67(2):153‐8.

Mrksic 2001 {published data only}

Mrksic M, Cabafi Z, Feher I, Mirkovic M. Operative trauma during laparoscopic and open cholecystectomy [Operativna trauma pri laparoskopskoj i klasicnoj holecistektomiji]. Medicinski Pregled 2001;54(7‐8):327‐31.

Novitsky 2002 {published data only}

Novitsky YW, Czerniach DR, Perugini RA, Yood SM, Kercher KW, Gallagher KA, et al. Prospective randomized trial of mini‐port vs conventional laparoscopic cholecystectomy [abstract]. Gastroenterology 2002;123(1):24.

Ogawa 2001 {published data only}

Ogawa T, Shimizu S, Mizumoto K, Uchiyama A, Yokohata K, Chijiiwa K, et al. Comparison of laparoscopic versus open cholecystectomy in patients with cardiac valve replacement. Journal of Hepato‐Biliary‐Pancreatic Surgery 2001;8(2):158‐60.

Olsen 1993 {published data only}

Olsen DO. Mini‐lap cholecystectomy. American Journal of Surgery 1993;165(4):440‐3.

Ortega 1996 {published data only}

Ortega AE, Peters JH, Incarbone R, Estrada L, Ehsan A, Kwan Y, et al. A prospective randomized comparison of the metabolic and stress hormonal responses of laparoscopic and open cholecystectomy. Journal of the American College of Surgeons 1996;183(3):249‐56.

Plaisier 1995 {published data only}

Plaisier PW, Van der Hul RL, Nijs HGT, Den Toom R, Terpstra OT, Bruining HA. Quality of life and the course of biliary and gastrointestinal symptoms after laparoscopic and conventional cholecystectomy. Digestive Surgery 1995;12:87‐91.

Prisco 2000 {published data only}

Prisco D, De Gaudio AR, Carla R, Gori AM, Fedi S, Cella AP, et al. Videolaparoscopic cholecystectomy induces a hemostasis activation of lower grade than does open surgery. Surgical Endoscopy 2000;14(2):170‐4.

Putensen‐Himmer 1992 {published data only}

Putensen‐Himmer G, Putensen C, Lammer H, Lingnau W, Aigner F, Benzer H. Comparison of postoperative respiratory function after laparoscopy or open laparotomy for cholecystectomy. Anesthesiology 1992;77(4):675‐80.

Rademaker 1992 {published data only}

Rademaker BM, Ringers J, Odoom JA, de Wit LT, Kalkman CJ, Oosting J. Pulmonary function and stress response after laparoscopic cholecystectomy: comparison with subcostal incision and influence of thoracic epidural analgesia. Anesthesia and Analgesia 1992;75(3):381‐5.

Redmond 1994 {published data only}

Redmond HP, Watson RWG, Houghton T, Condron C, Watson RGK, Bouchier‐Hayes D. Immune function in patients undergoing open vs laparoscopic cholecystectomy. Archives of Surgery 1994;129(12):1240‐6.

Rhodes 1996 {published data only}

Rhodes MG, Gompertz H, Armstrong K, Lennard T, Rees B. Randomised trial of laparoscopic versus small‐incision cholecystectomy [letter]. Lancet 1996;347(9015):1621‐2.

Romana 2000 {published data only}

Romana K, Avgoustatou K, Paparizou N, Korolanoglou D, Galanaki E, Karamichali E. Neuroendocrine responses to laparoscopic and open cholecystectomy [abstract]. European Journal of Anaesthesiology 2000;17:43.

Ros 2001 {published data only}

Nilsson E, Ros A, Rahmqvist M, Backman K, Carlsson P. Cholecystectomy: costs and health‐related quality of life: a comparison of two techniques. International Journal for Quality in Health Care 2004;16(6):473‐82.
Ros A, Gustafsson L, Krook H, Nordgren CE, Thorell A, Wallin G, et al. Laparoscopic cholecystectomy versus mini‐laparotomy cholecystectomy: a prospective, randomized, single‐blind study. Annals of Surgery 2001;234(6):741‐9.

Rovina 1996 {published data only}

Rovina N, Bouros D, Tzanakis N, Velegrakis M, Kandilakis S, Vlasserou F, et al. Effects of laparoscopic cholecystectomy on global respiratory muscle strength. American Journal of Respiratory and Critical Care Medicine 1996;153(1):458‐61.

Schauer 1993 {published data only}

Schauer PR, Luna J, Ghiatas AA, Glen ME, Warren JM, Sirinek KR. Pulmonary function after laparoscopic cholecystectomy. Surgery 1993;114(2):389‐97.

Schauer 1995 {published data only}

Schauer PR, Sirinek KR. The laparoscopic approach reduces the endocrine response to elective cholecystectomy. American Surgeon 1995;61(2):106‐11.

Schaupp 1988 {published data only}

Schaupp W, Menges HW, Schworm HD. The ideal cholecystectomy ‐ a prospective randomized study [Die 'ideale' Cholecystektomie ‐ eine prospektive, randomisierte Studie]. Chirurg 1988;59(10):661‐4.
Schaupp W, Menges HW, Trede M. The 'ideal' cholecystectomy: a prospective randomized study. Langenbecks Archiv fur Chirurgie 1987;372(Kongressbericht):839.

Secco 2002 {published data only}

Secco GB, Cataletti M, Bonfante P, Baldi E, Davini MD, Biasotti B, et al. Laparoscopic versus mini‐cholecystectomy: analysis of hospital costs and social costs in a prospective randomized study [Video‐colecistectomia versus mini‐colecistectomia: analisi dei costi ospedalieri e dei costi sociali in uno studio prospettico randomizzato]. Chirurgia Italiana 2002;54(5):685‐92.

Srivastava 2001 {published data only}

Srinivas G, Srivastava A, Misra MC, Pandav CS. Cost‐effectiveness analysis: laparoscopic versus minilaparotomy cholecystectomy for gallstone disease [abstract]. Clinical Economics 1998;51(Suppl 1):33S.
Srivastava A, Srinivas G, Misra MC, Pandav CS, Seenu V, Goyal A. Cost‐effectiveness analysis of laparoscopic versus minilaparotomy cholecystectomy for gallstone disease ‐ A randomized trial. International Journal of Technology Assessment in Health Care 2001;17(4):497‐502.

Tate 1993 {published data only}

Tate JJ, Lau WY, Leung KL, Li AK. Laparoscopic versus mini‐incision cholecystectomy. Lancet 1993;341(8854):1214‐5.

Thaler 1995 {published data only}

Thaler W, Frey L, Messmer K, Marzoli GP. Assessment of splanchnic blood flow by gastric tonometry in patients undergoing laparoscopic and open cholecystectomy. Langenbecks Archiv fur Chirurgie 1995;Suppl 1 Forumband:23‐6.

Toouli 1998 {published data only}

Toouli J, Wright TA. Gastroenterology ‐ 5. Gallstones. Medical Journal of Australia 1998;169(3):166‐71.

Trondsen 1993 {published data only}

Trondsen E, Reiertsen O, Andersen OK, Kjaersgaard P. Laparoscopic and open cholecystectomy ‐ a prospective, randomized study. European Journal of Surgery 1993;159(4):217‐21.

Ueo 1994 {published data only}

Ueo H, Honda M, Adachi M, Inoue H, Nakashima H, Arinaga S, et al. Minimal increase in serum interleukin‐6 levels during laparoscopic cholecystectomy. American Journal of Surgery 1994;168:358‐60.

Volpino 1998 {published data only}

Volpino P, Cangemi V, D'Andrea N, Cangemi B, Piat G. Hemodynamic and pulmonary changes during and after laparoscopic cholecystectomy. A comparison with traditional surgery. Surgical Endoscopy 1998;12(2):119‐23.

Williams 1993 {published data only}

Williams MD, Sulentich SM, Murr PC. Laparoscopic cholecystectomy produces less postoperative restriction of pulmonary function than open cholecystectomy. Surgical Endoscopy 1993;7(6):489‐92.

Yerdel 1997 {published data only}

Yerdel MA, Koksoy C, Aras N, Orita K. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective study. Surgical Laparoscopy & Endoscopy 1997;7(6):483‐6.

Zajac 1998 {published data only}

Zajac M, Zajac K, Engel Z. Laparoscopy vs laparotomy for cholecystectomy in elderly patients [abstract]. British Journal of Anaesthesia 1998;80(Suppl 1):2.

Zulfikaroglu 2002 {published data only}

Zulfikaroglu B, Koc M, Soran A, Isman FK, Cinel I. Evaluation of oxidative stress in laparoscopic cholecystectomy. Surgery Today 2002;32(10):869‐74.

Referencias adicionales

Assmann 2000

Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000;355:1064‐9.

Begg 1994

Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics 1994;50(4):1088‐101.

DeMets 1987

DeMets DL. Methods of combining randomized clinical trials: strengths and limitations. Statistics in Medicine 1987;6(3):341‐50.

DerSimonian 1986

DerSimonian R, Laird N. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177‐88.

Dubois 1982

Dubois F, Berthelot B. [Cholecystectomy through minimal incision (author's translation)]. Nouvelle Presse Medicale 1982;11(15):1139‐41.

Egger 1997

Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta‐analysis detected by a simple graphical test. BMJ (Clinical Research Ed.) 1997;315(7109):629‐34.

Egger 2003

Egger M, Davey SG, Schneider M, Binder C. Bias in meta‐analysis detected by a simple, graphical test. Health Technology Assessment 2003;7(1):1‐76.

Goco 1983

Goco IR, Chambers LG. "Mini‐cholecystectomy" and operative cholangiography. A means of cost containment. American Surgeon 1983;49(3):143‐5.

Higgins 2002

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21:1539‐58.

Higgins 2005

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. The Cochrane Library, Issue 3. Chichester, UK: John Wiley & Sons, Ltd, 2005.

Jüni 2001

Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ (Clinical Research Ed.) 2001;323(7303):42‐6.

Keus 2004

Keus, HG Gooszen, I van der Tweel, CJHM van Laarhoven. Laparoscopic, small‐incision, or open cholecystectomy for patients with symptomatic cholecystolithiasis. The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004788. DOI: 10.1002/14651858.CD004788.

Kjaergard 2001

Kjaergard LL, Villumsen J, Gluud C. Reported methodological quality and discrepancies between large and small randomised trials in meta‐analyses. Annals of Internal Medicine 2001;135(11):982‐9. [MEDLINE: 11730399]

Legorreta 1993

Legorreta AP, Silber JH, Costantino GN, Kobylinski RW, Zatz SL. Increased cholecystectomy rate after the introduction of laparoscopic cholecystectomy. Journal of the American Medical Association 1993;270(12):1429‐32.

Macaskill 2001

Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta‐analysis. Statistics in Medicine 2001;20:641‐54.

Moher 1998

Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta‐analyses. Lancet 1998;352(9128):609‐13. [MEDLINE: 9746022]

Mühe 1986

Mühe E. The first cholecystectomy through the laparoscope [Die erste Cholecystektomie durch das Laparoskop]. Langenbecks Archiv für Chirurgie 1986;369:804.

NIH Consensus 1993

NIH Consensus Development Panel on Gallstones and Laparoscopic Cholecystectomy. Journal of the American Medical Association 1993;269(8):1018‐24. [MEDLINE: 1993156112]

Olsen 1991

Olsen DO. Laparoscopic cholecystectomy. American Journal of Surgery 1991;161:339‐44. [MEDLINE: 1991158082]

RevMan 2003 [Computer program]

Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 4.2 for Windows. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2003.

Roslyn 1993

Roslyn JJ, Binns GS, Hughes EFX, Saunders‐Kirkwood K, Zinner MJ, Cates JA. Open cholecystectomy. A contemporary analysis of 42474 patients. Annals of Surgery 1993;218(2):129‐37.

Schmitz 1997a

Schmitz R, Rohde V, Treckman J, Shah S. Randomized trial of conventional cholecystectomy versus minicholecystectomy. British Journal of Surgery 1997;84(12):1683‐6.

Schulz 1995

Schulz KF, Chalmers I, Hayer R, Altman D. Empirical evidence of bias. Journal of the American Medical Association 1995;273(5):408‐12. [MEDLINE: 7823387]

Steiner 1994

Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP. Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. New England Journal of Medicine 1994;330(6):403‐8.

Sweeting 2004

Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta‐analysis of sparse data. Statistics in Medicine 2004;23:1351‐75.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Assalia 1993

Methods

Single‐centre randomised trial.

Generation of allocation: unclear.
Allocation concealment: unclear.
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Elective cholecystectomy for symptomatic cholelithiasis.

In‐ and exclusion criteria: not mentioned.

Comparability groups: well matched.

Interventions

SIC versus OC.

Minicholecystectomy: initial 5 cm (no preoperative ultrasound location), extended in stages each 1 cm long. Retrograde (fundus down) technique was performed.

Open cholecystectomy: technique was left to the individual surgeon. Length of incision: offer comfortable exposure, however, not too generous.

Antibiotic prophylaxis: yes.

Intra‐operative cholangiography: selectively carried out according to clinical and laboratory indications.

Outcomes

Primary and secondary outcome: not mentioned.

Outcomes: difficulty of the procedure, operative time, degree of pain, total amount of analgesia, hospital stay, patient satisfaction, physical activity limitations.

Duration of follow‐up: 2 weeks.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Free of other bias?

High risk

short follow‐up of 2 weeks

Coelho 1992a

Methods

Single‐centre trial.

Generation of allocation: adequate, by cards. (aleatoriamente = randomised).
Allocation concealment: unclear.
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Patients admitted for cholecystectomy.

In‐ and exclusion criteria: not very well described.

Comparability groups: well matched.

Interventions

SIC versus OC.

Both procedures not further specified.

Antibiotic prophylaxis: not mentioned.

Intra‐operative cholangiography: routinely performed in both groups.

Outcomes

Primary and secondary outcome: not described.

Outcome measures: clinical results.

Duration of follow‐up: hospital stay.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

Allocation concealment?

Unclear risk

B ‐ Unclear

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Coelho 1993

Methods

Single‐centre trial.

Generation of allocation: unclear. Patients randomly and prospectively divided into three groups.
Allocation concealment: unclear.
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Chronic calculous cholecystitis admitted for elective cholecystectomy.

In‐ and exclusion criteria: not described.

Comparability groups: well matched.

Interventions

LC versus SIC versus OC.

LC: four‐trocar technique, carbon dioxide insufflated.

SIC: right upper quadrant transverse incision of 5 to 8 cm.

OC: right upper quadrant subcostal incision of 15 to 20 cm.

Antibiotic prophylaxis: not mentioned.

Intra‐operative cholangiography: not mentioned.

Outcomes

Primary and secondary outcome: not defined.

Outcome measures: comparison of reduction in pulmonary function.

Duration of follow‐up: not mentioned.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Free of other bias?

High risk

unclear duration of follow‐up

O'Dwyer 1992

Methods

Two‐centre trial.

Generation of allocation: unclear.
Allocation concealment: adequate (sealed envelope).
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Patients having cholecystectomy for symptomatic gallstones.

In‐ and exclusion criteria: well described.

Comparability groups: well matched.

Interventions

SIC versus OC.

SIC: through 6 cm incision, rectus muscle divided.

OC: not further described.

Antibiotic prophylaxis: not mentioned.

Routine operative cholangiography in all patients.

Outcomes

Primary and secondary outcome: not specified.

Outcome measures: pulmonary, function tests, analgesia requirements, hospital stay.

Duration of follow‐up: hospital stay.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Free of other bias?

High risk

short follow‐up (hospital stay)

Schmitz 1997

Methods

Randomised clinical single‐centre trial.

Generation of allocation: unclear.
Allocation concealment: adequate.
Blinding: not performed.
Follow‐up: adequate. Drop‐outs: none; postoperative observation was extended to complete the investigation.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Patients for elective cholecystectomy.

In‐ and exclusion criteria: not very well described.

Comparability groups: well matched.

Interventions

SIC versus OC.

SIC: 6 cm subcostal transverse incision with diathermy transsection of the right rectus abdominis muscle.

OC: a 13 cm subcostal incision with additional partial extension into the muscle spaces of the right lateral epigastric region.

Antibiotic prophylaxis: not mentioned.

Intra‐operative cholangiography: not mentioned.

Outcomes

Primary and secondary outcome: not mentioned.

Outcome measures: operating times, level of subjective pain, analgesic intake, complications.

Duration of follow‐up: not mentioned.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Blinding?
All outcomes

High risk

Incomplete outcome data addressed?
All outcomes

Low risk

Free of selective reporting?

High risk

Free of other bias?

High risk

unclear duration of follow‐up

Seenu 1994

Methods

Single‐centre randomised trial, operations performed by consultants and senior residents.

Generation of allocation: unclear.
Allocation concealment: unclear.
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Patients undergoing elective cholecystectomy.

In‐ and exclusion criteria: not very well described.

Comparability groups: not very well described.

Interventions

SIC versus OC.

SIC: very well described, a 5 cm transverse incision in the right upper quadrant.

OC: vertical midline incision.

Antibiotic prophylaxis: not mentioned.

Intra‐operative cholangiography: no, selective pre‐operative cholangiogram was performed when necessary.

Outcomes

Primary and secondary outcome: not mentioned.

Outcome measures: complications, operative time, hospital stay.

Duration of follow‐up: 30 days.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Wani 2002

Methods

Single‐centre trial. Randomised trial: prospective study with patients systematically divided.

Generation of allocation: unclear.
Allocation concealment: unclear.
Blinding: not performed.
Follow‐up: unclear. Drop‐outs: none mentioned.

Intention‐to‐treat: not mentioned.
Sample size calculations: no.

Participants

Patients with chronic calculus cholecystitis.

In‐ and exclusion criteria: not very well described.

Comparability groups: well matched.

Interventions

SIC versus OC.

SIC: incision of 5 cm to 7 cm length with two well illuminated retractors, dissected either duct first or fundus first.

OC: right subcostal incision of 10 cm to 15 cm.

Antibiotic prophylaxis: not mentioned.

Intra‐operative cholangiography: not mentioned

Outcomes

Primary and secondary outcome: not mentioned.

Outcome measures: pulmonary function.

Duration of follow‐up: not mentioned (hospital stay).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Blinding?
All outcomes

High risk

Free of selective reporting?

High risk

Free of other bias?

Unclear risk

short follow‐up

LC ‐ laparoscopic cholecystectomy,
SIC ‐ small‐incision cholecystectomy,
OC ‐ open cholecystectomy.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Agnifili 1993

Randomised trial evaluating laparoscopic and open cholecystectomy.

Al Tameem 1995

Prospective study on three different types of small‐incision cholecystectomy, not randomised.

Alexander 1997

Review on pain after laparoscopy; not a randomised trial.

Allen 2002

Comparison of costs of LC between ten surgeons; no comparison of operative procedures.

Alponat 2002

Randomised clinical trial on conventional LC (two 10 mm and two 5 mm ports) and LC by small instruments (one 10 mm and three 2 mm ports); thus comparison of two types of LC.

Anonymous 1995

Editorial: discussion of other article.

Assalia 1997

Randomised trial only including patients with acute cholecystitis.

Bablekos 2003

Correspondence with GD Bablekos on 11 October 2004: separating patients in triads with allocation according to registration sequence at the emergency ward: quasi‐randomised study of LC versus OC.

Barkun 1992

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Barkun 1993

Comparison of three different time periods; not a randomised trial.

Baxter 1992

Debate, consideration.

Bellon 1998

Randomised trial evaluating laparoscopic and open cholecystectomy.

Berggren 1994

Randomised trial evaluating laparoscopic and open cholecystectomy.

Bernard 1994

Economic evaluation.

Bigard 1995

Review on indications and methods of cholecystectomy in treatment of gallstones.

Blanc‐Louvry 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Blomstedt 1972

Study on the frequency of incisional hernias after different types of conventional cholecystectomy; not a randomised trial.

Bolke 2000

Quasi‐randomised trial: "... patients were randomised by alternate number to LC or OC ...".

Bruce 1999

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Bukan 2004

Randomised trial evaluating laparoscopic and open cholecystectomy.

Byrne 1994

Prospective, not randomised study: " ... equipment was only made available on an intermittent basis ...".

Calland 2001

Prospective study on outpatient LC, comparing with historical (inpatient) LC; not a randomised trial.

Caplan 1999

Study on costs and patient satisfaction before and after re‐engineering of a surgical service in LC patients and elective herniorrhaphy; no comparison of different types of cholecystectomy.

Champault 2002

One‐arm prospective study on costs; not a randomised trial (not two arms).

Charlo 1995

Randomised trial evaluating laparoscopic and open cholecystectomy.

Chaudhary 1999

Randomised trial evaluating laparoscopic and open cholecystectomy.

Chumillas 1998

Randomised trial evaluating laparoscopic and open cholecystectomy.

Clezy 1996

Letter.

Coelho 1992

Not a randomised trial; prospective study of small‐incision cholecystectomy.

Coskun 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Da Costa 1995

Prospective study, not randomised: "... patients were not randomised as it was felt that it was unethical to do so ...".

Dauleh 1995

Randomised trial evaluating laparoscopic and open cholecystectomy.

Decker 1993

Not randomised; prospective study.

Delogu 1999

Stress response in LC and OC patients, not randomised: "... 22 patients underwent OC and the other 24 had LC according to the availability of laparoscopic equipment ...".

Demirer 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Dionigi 1994

Randomised trial evaluating laparoscopic and open cholecystectomy.

Dohrmann 1993

Not randomised; randomisation was not possible as most patients opted for the laparoscopic technique.

Eickhoff 1997

Not a randomised trial: patients who were operated by LC or OC were analysed.

Engin 1998

Randomised trial evaluating laparoscopic and open cholecystectomy

Essen 1995

Randomised trial evaluating laparoscopic and open cholecystectomy.

Frazee 1991

No correct randomisation between two operative techniques: "... patients were randomly assigned to individual staff surgeons, as is our customary practice ...".

Gal 1997

Randomised trial evaluating laparoscopic and open cholecystectomy.

Galizia 2001

Randomised trial evaluating laparoscopic and open cholecystectomy.

GarciaCaballero 1993

Randomised trial evaluating laparoscopic and open cholecystectomy.

Glaser 1995

Prospective study with control group, not randomised: "... because of the ethical problems associated with randomisation of LC and OC, we decided to conduct a prospective trial without randomisation, but with a control group ...".

Go 1995

Retrospective study on cost‐effectiveness between extracorporeal shock‐wave lithotripsy, conventional cholecystectomy, and laparoscopic cholecystectomy.

Grande 2002

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Hagmuller 1997

Not randomised: the authors felt that randomisation was not possible on ethical grounds.

Hasukic 2002

Randomised trial evaluating laparoscopic and open cholecystectomy.

Hauer‐Jensen 1986

Randomised trial comparing performing cholecystectomy with or without a routine cholangiography.

Hendolin 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Hobbs 1995

Considerations on laparoscopic cholecystectomy, not a randomised trial.

Huang 1996

Randomised trial evaluating laparoscopic and open cholecystectomy.

Huguier 1997

Considerations on laparoscopic digestive surgery, not a randomised trial.

Hunter 2001

Editorial.

Iwase 1992

Not a randomised trial.

Jan 1993

Randomised trial evaluating laparoscopic and open cholecystectomy.

Johnson 1997

Considerations on laparoscopic surgery.

Johnson 1998

Personal view: consideration on efficacy, safety and training; not a randomised trial.

Johnson 1998a

Letter.

Karayiannakis 1997

Randomised trial evaluating laparoscopic and open cholecystectomy.

Karayiannakis 2002

Prospective study in patients having LC and OC, but no randomisation: "... twelve patients who had OC were recruited and served as the control group ...".

Kehlet 1993

Consideration of gallstone treatment modalities.

Keus 2006

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Kiviluoto 1997

Randomised trial between LC and OC on acute cholecystitis.

Kjaersgaard 1994

Randomised trial evaluating laparoscopic and open cholecystectomy.

Koprulu 1996

Randomised trial evaluating laparoscopic and open cholecystectomy.

Krasinski 1998

Prospective study on patients who underwent LC: patients with uncomplicated LC were compared to patients who had conversion from LC to OC.

Krawczyk 1993

Not a randomised trial: "the groups were not randomised".

Kunz 1992

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Kurzawinski 1992

Prospective study, but not randomised: "... patients were randomly allocated to either LC or OC, based on the availability of laparoscopic equipment ...".

Lam 1996

Survey in Scotland on cholecystectomy rate; not a randomised trial.

Lausten 1999 (1)

Randomised trial evaluating laparoscopic and open cholecystectomy.

Lausten 1999 (2)

Randomised trial evaluating laparoscopic and open cholecystectomy.

Lujan 1998

Randomised trial evaluating laparoscopic and open cholecystectomy.

Lukichev 1983

Cohort of patients treated by one technique; not a randomised trial.

Luo 2003

Randomised trial evaluating laparoscopic and open cholecystectomy.

Majeed 1996

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Makinen 1995

Only pilot phase of trial; in pilot phase no randomisation: SIC was performed when LC instruments were not available.

Malaysian HTA 2005

Systematic review on different types of minimal access surgery; not a randomised trial.

Maruszynski 1995

Patients with acute cholecystitis only.

Matsunaga 1996

Comparison of two different types of anaesthesia in cholecystectomy.

McGinn 1995

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

McKellar 1995

Comparison of historical cohorts.

McMahon 1994

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

McMahon 1996

Letter, not a randomised trial.

Mealy 1992

An unselected group of patients undergoing LC in one hospital was compared with a group undergoing OC in another hospital.

Milheiro 1994

Randomised trial evaluating laparoscopic and open cholecystectomy.

Mimica 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Mrksic 2001

No randomisation.

Novitsky 2002

Randomised controlled trial on two types of laparoscopic cholecystectomy (mini‐port LC (2 mm) versus conventional LC).

Ogawa 2001

Retrospective study on LC versus OC in patients with cardiac valve replacement.

Olsen 1993

Review of literature from 1970 to 1992 on mini‐lap cholecystectomy: only articles in English were included and data on conventional and laparoscopic cholecystectomy were obtained from large series reported in literature.

Ortega 1996

Randomised trial evaluating laparoscopic and open cholecystectomy.

Plaisier 1995

Prospective not randomised study: "... allocation to either laparoscopic or conventional cholecystectomy depended on the availability of a laparoscopic set ...".

Prisco 2000

Randomised trial evaluating laparoscopic and open cholecystectomy.

Putensen‐Himmer 1992

Randomised trial evaluating laparoscopic and open cholecystectomy.

Rademaker 1992

Patients underwent conventional subcostal cholecystectomy whenever the instrumentation for laparoscopic surgery was not available; the laparoscopic group had on alternating basis general anaesthesia combined with epidural analgesia or general anaesthesia alone; not randomised.

Redmond 1994

Study evaluating laparoscopic and small‐incision cholecystectomy.

Rhodes 1996

Not a randomised trial; comment on other article.

Romana 2000

Not randomised: "patients were divided into two groups".

Ros 2001

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Rovina 1996

Randomised trial evaluating laparoscopic and open cholecystectomy.

Schauer 1993

No correct randomisation of surgical techniques: ".. patients were randomly assigned to one of four general surgical services; two of these used only the open cholecystectomy technique, and the other two used the laparoscopic approach ..".

Schauer 1995

Not randomised; ".. procedure was determined by the attending physician ..".

Schaupp 1988

Randomised clinical trial on two types of conventional cholecystectomy (with nasogastric tube, iv infusion and subhepatic drain versus no tube, no infusion and no drain).

Secco 2002

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Srivastava 2001

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Tate 1993

Randomised trial evaluating laparoscopic and small‐incision cholecystectomy.

Thaler 1995

Trial on LC and OC patients, but no randomisation as the authors found that laparoscopic cholecystectomy was the method of first choice.

Toouli 1998

Review on gallstones; not a randomised trial.

Trondsen 1993

Randomised trial evaluating laparoscopic and open cholecystectomy.

Ueo 1994

Prospective comparison between IL‐6 levels in LC and OC patients, but not randomised: " ... patients who underwent cholecystectomy, 12 each for OC and LC, were chosen as subjects in this study ...".

Volpino 1998

Randomised trial evaluating laparoscopic and open cholecystectomy.

Williams 1993

Prospective study on LC and OC pulmonary function, but not randomised: "... selection for OC or LC depended upon surgeon ...".

Yerdel 1997

Prospective study in cirrhotic patients on laparoscopic versus open cholecystectomy; not randomised ( "... all cirrhotic patients were offered LC ..." ).

Zajac 1998

Randomised trial evaluating laparoscopic and open cholecystectomy.

Zulfikaroglu 2002

Randomised trial evaluating laparoscopic and open cholecystectomy.

LC: laparoscopic cholecystectomy;
OC: open cholecystectomy.

Data and analyses

Open in table viewer
Comparison 1. SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 1.1

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 1 Intra‐operative complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 1 Intra‐operative complications.

1.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.07, 0.07]

1.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

Analysis 1.2

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 2 Minor complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 2 Minor complications.

2.1 High‐quality trials

1

50

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.21, 0.13]

2.2 Low‐quality trials

6

521

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.07]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

Analysis 1.3

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 3 Severe complications (without bile duct injuries).

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 3 Severe complications (without bile duct injuries).

3.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

‐0.04 [‐0.14, 0.06]

3.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 1.4

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 4 Bile duct injuries.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 4 Bile duct injuries.

4.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.07, 0.07]

4.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

Analysis 1.5

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 5 Total complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 5 Total complications.

5.1 High‐quality trials

1

50

Risk Difference (M‐H, Random, 95% CI)

‐0.08 [‐0.26, 0.10]

5.2 Low‐quality trials

6

521

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.08]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

Analysis 1.6

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 6 Operative time (minutes).

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 6 Operative time (minutes).

6.1 High‐quality trials

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Low‐quality trials

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Analysis 1.7

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 7 Hospital stay (days).

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 7 Hospital stay (days).

7.1 High‐quality trials

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Low‐quality trials

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Open in table viewer
Comparison 2. SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 2.1

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 1 Intra‐operative complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 1 Intra‐operative complications.

1.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

1.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

Analysis 2.2

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 2 Minor complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 2 Minor complications.

2.1 High‐quality trials

2

160

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.02, 0.21]

2.2 Low‐quality trials

5

411

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.02]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

Analysis 2.3

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 3 Severe complications (without bile duct injuries).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 3 Severe complications (without bile duct injuries).

3.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.02 [‐0.03, 0.08]

3.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

‐0.02 [‐0.06, 0.01]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 2.4

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 4 Bile duct injuries.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 4 Bile duct injuries.

4.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

4.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

Analysis 2.5

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 5 Total complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 5 Total complications.

5.1 High‐quality trials

2

160

Risk Difference (M‐H, Random, 95% CI)

0.14 [0.04, 0.24]

5.2 Low‐quality trials

5

411

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.03]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

Analysis 2.6

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 6 Operative time (minutes).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 6 Operative time (minutes).

6.1 High‐quality trials

2

160

Mean Difference (IV, Fixed, 95% CI)

2.81 [‐1.78, 7.41]

6.2 Low‐quality trials

1

50

Mean Difference (IV, Fixed, 95% CI)

1.0 [‐3.77, 5.77]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Analysis 2.7

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 7 Hospital stay (days).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 7 Hospital stay (days).

7.1 High‐quality trials

1

130

Mean Difference (IV, Random, 95% CI)

‐3.9 [‐4.57, ‐3.23]

7.2 Low‐quality trials

1

50

Mean Difference (IV, Random, 95% CI)

‐1.70 [‐2.05, ‐1.35]

Open in table viewer
Comparison 3. SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 3.1

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 1 Intra‐operative complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 1 Intra‐operative complications.

1.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

Analysis 3.2

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 2 Minor complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 2 Minor complications.

2.1 High‐quality trials

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Low‐quality trials

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

Analysis 3.3

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 3 Severe complications (without bile duct injuries).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 3 Severe complications (without bile duct injuries).

3.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 3.4

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 4 Bile duct injuries.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 4 Bile duct injuries.

4.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

Analysis 3.5

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 5 Total complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 5 Total complications.

5.1 High‐quality trials

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Low‐quality trials

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

Analysis 3.6

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 6 Operative time (minutes).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 6 Operative time (minutes).

6.1 High‐quality trials

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Low‐quality trials

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Analysis 3.7

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 7 Hospital stay (days).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 7 Hospital stay (days).

7.1 High‐quality trials

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Low‐quality trials

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Open in table viewer
Comparison 4. SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 4.1

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 1 Intra‐operative complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 1 Intra‐operative complications.

1.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

1.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

Analysis 4.2

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 2 Minor complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 2 Minor complications.

2.1 High‐quality trials

1

130

Risk Difference (M‐H, Random, 95% CI)

0.14 [0.03, 0.25]

2.2 Low‐quality trials

6

441

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.03]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

Analysis 4.3

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 3 Severe complications (without bile duct injuries).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 3 Severe complications (without bile duct injuries).

3.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.03 [‐0.02, 0.08]

3.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

‐0.02 [‐0.05, 0.01]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

Analysis 4.4

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 4 Bile duct injuries.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 4 Bile duct injuries.

4.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

4.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

Analysis 4.5

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 5 Total complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 5 Total complications.

5.1 High‐quality trials

1

130

Risk Difference (M‐H, Random, 95% CI)

0.17 [0.05, 0.29]

5.2 Low‐quality trials

6

441

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

Analysis 4.6

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 6 Operative time (minutes).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 6 Operative time (minutes).

6.1 High‐quality trials

1

130

Mean Difference (IV, Fixed, 95% CI)

4.0 [‐0.86, 8.86]

6.2 Low‐quality trials

2

80

Mean Difference (IV, Fixed, 95% CI)

0.16 [‐4.35, 4.68]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Analysis 4.7

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 7 Hospital stay (days).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 7 Hospital stay (days).

7.1 High‐quality trials

1

130

Mean Difference (IV, Random, 95% CI)

‐3.9 [‐4.57, ‐3.23]

7.2 Low‐quality trials

1

50

Mean Difference (IV, Random, 95% CI)

‐1.70 [‐2.05, ‐1.35]

Open in table viewer
Comparison 5. SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Sensitivity analysis 1: Operative time (minutes) Show forest plot

7

571

Mean Difference (IV, Random, 95% CI)

‐2.98 [‐7.86, 1.90]

Analysis 5.1

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 1 Sensitivity analysis 1: Operative time (minutes).

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 1 Sensitivity analysis 1: Operative time (minutes).

2 Sensitivity analysis 2: Hospital stay (days) Show forest plot

7

571

Mean Difference (IV, Random, 95% CI)

‐1.97 [‐2.56, ‐1.39]

Analysis 5.2

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 2 Sensitivity analysis 2: Hospital stay (days).

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 2 Sensitivity analysis 2: Hospital stay (days).

3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications Show forest plot

6

441

Risk Difference (M‐H, Fixed, 95% CI)

‐0.04 [‐0.09, 0.01]

Analysis 5.3

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications.

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Funnel plot on small‐incision versus open cholecystectomy regarding concealment of allocation considering total complications, including 95% confidence interval lines. No arguments for bias.
Figuras y tablas -
Figure 3

Funnel plot on small‐incision versus open cholecystectomy regarding concealment of allocation considering total complications, including 95% confidence interval lines. No arguments for bias.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 1 Intra‐operative complications.
Figuras y tablas -
Analysis 1.1

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 1 Intra‐operative complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 2 Minor complications.
Figuras y tablas -
Analysis 1.2

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 2 Minor complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 3 Severe complications (without bile duct injuries).
Figuras y tablas -
Analysis 1.3

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 3 Severe complications (without bile duct injuries).

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 4 Bile duct injuries.
Figuras y tablas -
Analysis 1.4

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 4 Bile duct injuries.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 5 Total complications.
Figuras y tablas -
Analysis 1.5

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 5 Total complications.

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 6 Operative time (minutes).
Figuras y tablas -
Analysis 1.6

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 6 Operative time (minutes).

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 7 Hospital stay (days).
Figuras y tablas -
Analysis 1.7

Comparison 1 SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence, Outcome 7 Hospital stay (days).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 1 Intra‐operative complications.
Figuras y tablas -
Analysis 2.1

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 1 Intra‐operative complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 2 Minor complications.
Figuras y tablas -
Analysis 2.2

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 2 Minor complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 3 Severe complications (without bile duct injuries).
Figuras y tablas -
Analysis 2.3

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 3 Severe complications (without bile duct injuries).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 4 Bile duct injuries.
Figuras y tablas -
Analysis 2.4

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 4 Bile duct injuries.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 5 Total complications.
Figuras y tablas -
Analysis 2.5

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 5 Total complications.

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 6 Operative time (minutes).
Figuras y tablas -
Analysis 2.6

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 6 Operative time (minutes).

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 7 Hospital stay (days).
Figuras y tablas -
Analysis 2.7

Comparison 2 SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation, Outcome 7 Hospital stay (days).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 1 Intra‐operative complications.
Figuras y tablas -
Analysis 3.1

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 1 Intra‐operative complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 2 Minor complications.
Figuras y tablas -
Analysis 3.2

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 2 Minor complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 3 Severe complications (without bile duct injuries).
Figuras y tablas -
Analysis 3.3

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 3 Severe complications (without bile duct injuries).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 4 Bile duct injuries.
Figuras y tablas -
Analysis 3.4

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 4 Bile duct injuries.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 5 Total complications.
Figuras y tablas -
Analysis 3.5

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 5 Total complications.

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 6 Operative time (minutes).
Figuras y tablas -
Analysis 3.6

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 6 Operative time (minutes).

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 7 Hospital stay (days).
Figuras y tablas -
Analysis 3.7

Comparison 3 SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding, Outcome 7 Hospital stay (days).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 1 Intra‐operative complications.
Figuras y tablas -
Analysis 4.1

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 1 Intra‐operative complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 2 Minor complications.
Figuras y tablas -
Analysis 4.2

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 2 Minor complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 3 Severe complications (without bile duct injuries).
Figuras y tablas -
Analysis 4.3

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 3 Severe complications (without bile duct injuries).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 4 Bile duct injuries.
Figuras y tablas -
Analysis 4.4

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 4 Bile duct injuries.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 5 Total complications.
Figuras y tablas -
Analysis 4.5

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 5 Total complications.

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 6 Operative time (minutes).
Figuras y tablas -
Analysis 4.6

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 6 Operative time (minutes).

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 7 Hospital stay (days).
Figuras y tablas -
Analysis 4.7

Comparison 4 SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up, Outcome 7 Hospital stay (days).

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 1 Sensitivity analysis 1: Operative time (minutes).
Figuras y tablas -
Analysis 5.1

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 1 Sensitivity analysis 1: Operative time (minutes).

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 2 Sensitivity analysis 2: Hospital stay (days).
Figuras y tablas -
Analysis 5.2

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 2 Sensitivity analysis 2: Hospital stay (days).

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications.
Figuras y tablas -
Analysis 5.3

Comparison 5 SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data, Outcome 3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications.

Table 1. Randomised, excluded, and included in small‐incision vs open cholecystectomy

Trial

Randomised

Excluded

Included SIC

Included OC

Cholangiography

Antibiotics

Surgical expertise

Assalia 1993

50

0

24

26

N

Y

S

Coelho 1992a

50

0

25

25

Y

U

U

Coelho 1993

45*

0

15

15

U

U

U

O'Dwyer 1992a

30

0

16

14

Y

U

R

Schmitz 1997a

130

0

65

65

U

U

U

Seenu 1994

181

0

97

84

U

U

R

Wani 2002

100

0

50

50

U

U

U

Total

586

0

292

279

* three‐arm trial, patients in the LC group not listed in this table.

N = no

Y = yes

U = unknown

S = one surgeon

R = also registrars

Figuras y tablas -
Table 1. Randomised, excluded, and included in small‐incision vs open cholecystectomy
Table 2. Description of background data (age, sex, BMI, and ASA)

Trial

N

Age

Age

Sex (m/f)

Sex (m/f)

BMI

BMI

ASA (I‐II‐III‐IV)

ASA (I‐II‐III‐IV)

SIC vs OC

randomised

SIC

OC

SIC

OC

SIC

OC

SIC

OC

Assalia 1993

24 / 26

60.3 (12.1)

59.2 (13.4)

5 / 19

7 / 19

Coelho 1992a

25 / 25

46 ( ‐ )

45 ( ‐ )

2 / 23

4 / 21

Coelho 1993

15 / 15

42.5 (25‐66)

45.4 (18‐73)

2 / 13

3 / 12

O'Dwyer 1992a

16 / 14

46 (27‐74)

51 (38‐73)

3 / 13

4 / 10

16 ‐ 0 ‐ 0 ‐ 0

14 ‐ 0 ‐ 0 ‐ 0

Schmitz 1997a

65 / 65

52.6 (14.6)

54.1 (12.2)

20 / 45

23 / 42

Seenu 1994

97 / 84

Wani 2002

50 / 50

34.8 (5.6)

37.4 (6.2)

5 / 45

5 / 45

21.5 (1.9)

21.6 (1.8)

mean (standard deviation / range)

Figuras y tablas -
Table 2. Description of background data (age, sex, BMI, and ASA)
Table 3. Complications specified per operative technique: small‐incision vs open cholecys

Complications

SIC

OC

INTRA‐OPERATIVE

(0)

(0)

POSTOPERATIVE ‐ MINOR

(25 / 8.6%)

(19 / 6.8%)

wound hematoma

12

4

wound infection

12

15

urinary retention

1

0

POSTOPERATIVE ‐ SEVERE

(4 / 1.4%)

(7 / 2.5%)

stone left in cystic duct (re‐operation)

1

0

pneumonia

1

5

atelectasis

1

0

cardiovascular

1

0

upper GI bleeding (endoscopy / conservative)

0

2

BILE DUCT INJURY

(0)

(0)

TOTAL COMPLICATIONS

29 (9.9%)

26 (9.3%)

RE‐OPERATIONS (all complications)

2 (0.7%)

0

TOTAL NUMBER OF PATIENTS INCLUDED (all trials)

292

279

Figuras y tablas -
Table 3. Complications specified per operative technique: small‐incision vs open cholecys
Table 4. Internal validity assessment of included trials: small‐incision vs open cholecys

Trial

Generation of alloc

Concealment of alloc

Blinding

Follow‐up

Assalia 1993

U

U

N

U

Coelho 1992a

A

U

N

U

Coelho 1993

U

U

N

U

O'Dwyer 1992a

U

A

N

U

Schmitz 1997a

U

A

N

A

Seenu 1994

U

U

N

U

Wani 2002

U

U

N

U

A: Adequate

U: Unclear

I: Inadequate

N: Not performed

Figuras y tablas -
Table 4. Internal validity assessment of included trials: small‐incision vs open cholecys
Table 5. Results of small‐incision vs open cholecystectomy: alloc. concealment (compar.2)

Outcome

RD/WMD

HQ/LQ/AT

Fixed

Random

Discrepancy

Emphasize

HQ‐LQ difference

Significant

Minor complications

RD

HQ

0.12 (0.03, 0.22) *

0.11 (0.02, 0.21) *

no

LQ

‐0.03 (‐0.07, 0.02)

‐0.01 (‐0.04, 0.02)

no

AT

0.02 (‐0.03, 0.06)

0.01 (‐0.03, 0.05)

no

random

yes

yes/no

Total complications

RD

HQ

0.15 (0.04, 0.25) *

0.14 (0.04, 0.24) *

no

LQ

‐0.05 (‐0.10, 0.00)

‐0.03 (‐0.10, 0.03)

no

AT

0.01 (‐0.04, 0.05)

0.00 (‐0.06, 0.07)

no

random

yes

yes/no

Hospital stay

WMD

HQ

‐3.90 (‐4.57, ‐3.23) *

‐3.90 (‐4.57, ‐3.23) *

no

LQ

‐1.70 (‐2.05, ‐1.35) *

‐1.70 (‐2.05, ‐1.35) *

no

AT

‐2.16 (‐2.47, ‐1.85) *

‐2.78 (‐4.94, ‐0.62) *

no

random

no

yes

* significant result

HQ: high‐quality trials

LQ: low‐quality trials

AT: all trials

RD: risk difference

WMD: weighted mean difference

random: random‐effects model

Figuras y tablas -
Table 5. Results of small‐incision vs open cholecystectomy: alloc. concealment (compar.2)
Table 6. Operative time small‐incision vs open cholecystectomy: all available data

Trial

Type of data

SIC ‐ mean/median

SIC ‐ SD/range

OC ‐ mean/median

OC ‐ SD/range

Skewness SIC

Skewness OC

Assalia 1993

A ‐ SD

60

8.7

59

8.5

6.90

6.94

Coelho 1992a

A ‐

86

99

Coelho 1993

A ‐ range

74

40 ‐ 125

86

40 ‐ 140

O'Dwyer 1992a

A ‐ SD

62

22

69

17

2.82

4.06

Schmitz 1997a

A ‐ SD

62

16

58

12

3.88

4.83

Seenu 1994

A ‐ range

60

30 ‐ 100

65

20 ‐ 90

Wani 2002

A ‐ range

74

40 ‐ 125

70

50 ‐ 125

A: Average / mean

SD: standard deviation

Figuras y tablas -
Table 6. Operative time small‐incision vs open cholecystectomy: all available data
Table 7. Hospital stay small‐incision vs open cholecystectomy: all available data

Trial

Type of data

SIC ‐ mean/median

SIC ‐ SD/range

OC ‐ mean/median

OC ‐ SD/range

Skewness SIC

Skewness OC

Assalia 1993

A ‐ SD

3

0.4

4.7

0.8

7.5

5.88

Coelho 1992a

A ‐

1,7

3,5

Coelho 1993

A ‐ range

1

1 ‐ 1

2

2 ‐ 3

O'Dwyer 1992a

M ‐ range

3

1 ‐ 10

5

3 ‐ 8

Schmitz 1997a

A ‐ SD

11.5

1.2

15.4

2.5

9.58

6.16

Seenu 1994

A ‐ range

2.6

1 ‐ 4

4

3 ‐ 8

Wani 2002

A ‐

3

5

A: Average / mean

SD: standard deviation

M: median

Figuras y tablas -
Table 7. Hospital stay small‐incision vs open cholecystectomy: all available data
Comparison 1. SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

1.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.07, 0.07]

1.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

2.1 High‐quality trials

1

50

Risk Difference (M‐H, Random, 95% CI)

‐0.04 [‐0.21, 0.13]

2.2 Low‐quality trials

6

521

Risk Difference (M‐H, Random, 95% CI)

0.02 [‐0.04, 0.07]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

‐0.04 [‐0.14, 0.06]

3.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

4.1 High‐quality trials

1

50

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.07, 0.07]

4.2 Low‐quality trials

6

521

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

5.1 High‐quality trials

1

50

Risk Difference (M‐H, Random, 95% CI)

‐0.08 [‐0.26, 0.10]

5.2 Low‐quality trials

6

521

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.06, 0.08]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

6.1 High‐quality trials

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Low‐quality trials

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Low‐quality trials

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Figuras y tablas -
Comparison 1. SIC versus OC ‐ high‐quality and low‐quality trials regarding generation of the allocation sequence
Comparison 2. SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

1.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

1.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

2.1 High‐quality trials

2

160

Risk Difference (M‐H, Random, 95% CI)

0.11 [0.02, 0.21]

2.2 Low‐quality trials

5

411

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.02]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.02 [‐0.03, 0.08]

3.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

‐0.02 [‐0.06, 0.01]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

4.1 High‐quality trials

2

160

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

4.2 Low‐quality trials

5

411

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

5.1 High‐quality trials

2

160

Risk Difference (M‐H, Random, 95% CI)

0.14 [0.04, 0.24]

5.2 Low‐quality trials

5

411

Risk Difference (M‐H, Random, 95% CI)

‐0.03 [‐0.10, 0.03]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

6.1 High‐quality trials

2

160

Mean Difference (IV, Fixed, 95% CI)

2.81 [‐1.78, 7.41]

6.2 Low‐quality trials

1

50

Mean Difference (IV, Fixed, 95% CI)

1.0 [‐3.77, 5.77]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials

1

130

Mean Difference (IV, Random, 95% CI)

‐3.9 [‐4.57, ‐3.23]

7.2 Low‐quality trials

1

50

Mean Difference (IV, Random, 95% CI)

‐1.70 [‐2.05, ‐1.35]

Figuras y tablas -
Comparison 2. SIC versus OC ‐ high‐quality and low‐quality trials regarding concealment of allocation
Comparison 3. SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

1.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

2.1 High‐quality trials

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 Low‐quality trials

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

4.1 High‐quality trials

0

0

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Low‐quality trials

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

5.1 High‐quality trials

0

0

Risk Difference (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 Low‐quality trials

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

6.1 High‐quality trials

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Low‐quality trials

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

7.2 Low‐quality trials

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

Figuras y tablas -
Comparison 3. SIC versus OC ‐ high‐quality and low‐quality trials regarding blinding
Comparison 4. SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Intra‐operative complications Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

1.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

1.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

2 Minor complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.03, 0.05]

2.1 High‐quality trials

1

130

Risk Difference (M‐H, Random, 95% CI)

0.14 [0.03, 0.25]

2.2 Low‐quality trials

6

441

Risk Difference (M‐H, Random, 95% CI)

‐0.01 [‐0.04, 0.03]

3 Severe complications (without bile duct injuries) Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

‐0.01 [‐0.04, 0.02]

3.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.03 [‐0.02, 0.08]

3.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

‐0.02 [‐0.05, 0.01]

4 Bile duct injuries Show forest plot

7

571

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

4.1 High‐quality trials

1

130

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.03, 0.03]

4.2 Low‐quality trials

6

441

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.02, 0.02]

5 Total complications Show forest plot

7

571

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.06, 0.07]

5.1 High‐quality trials

1

130

Risk Difference (M‐H, Random, 95% CI)

0.17 [0.05, 0.29]

5.2 Low‐quality trials

6

441

Risk Difference (M‐H, Random, 95% CI)

‐0.02 [‐0.07, 0.03]

6 Operative time (minutes) Show forest plot

3

210

Mean Difference (IV, Fixed, 95% CI)

1.94 [‐1.37, 5.25]

6.1 High‐quality trials

1

130

Mean Difference (IV, Fixed, 95% CI)

4.0 [‐0.86, 8.86]

6.2 Low‐quality trials

2

80

Mean Difference (IV, Fixed, 95% CI)

0.16 [‐4.35, 4.68]

7 Hospital stay (days) Show forest plot

2

180

Mean Difference (IV, Random, 95% CI)

‐2.78 [‐4.94, ‐0.62]

7.1 High‐quality trials

1

130

Mean Difference (IV, Random, 95% CI)

‐3.9 [‐4.57, ‐3.23]

7.2 Low‐quality trials

1

50

Mean Difference (IV, Random, 95% CI)

‐1.70 [‐2.05, ‐1.35]

Figuras y tablas -
Comparison 4. SIC versus OC ‐ high‐quality and low‐quality trials regarding follow‐up
Comparison 5. SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Sensitivity analysis 1: Operative time (minutes) Show forest plot

7

571

Mean Difference (IV, Random, 95% CI)

‐2.98 [‐7.86, 1.90]

2 Sensitivity analysis 2: Hospital stay (days) Show forest plot

7

571

Mean Difference (IV, Random, 95% CI)

‐1.97 [‐2.56, ‐1.39]

3 Sensitivity analysis 3: Omitting outlier Schmitz in total complications Show forest plot

6

441

Risk Difference (M‐H, Fixed, 95% CI)

‐0.04 [‐0.09, 0.01]

Figuras y tablas -
Comparison 5. SIC versus OC ‐ sensitivity analysis imputing medians and standard deviations for missing data