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Pengurusan surgikal berbanding bukan surgikal untuk empiema pleural

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Referencias

Bilgin 2006 {published data only}

Bilgin M, Akcali Y, Oguzkaya F. Benefits of early aggressive management of empyema thoracis. ANZ Journal of Surgery 2006;76(3):120‐2. CENTRAL

Cobanoglu 2011 {published data only}

Cobanoglu U, Sayir F, Bilici S, Melek M. Comparison of the methods of fibrinolysis by tube thoracostomy and thoracoscopic decortication in children with stage II and III empyema: a prospective randomized study. Pediatric Reports 2011;3(4):e29. CENTRAL

Karaman 2004 {published data only}

Karaman I, Erdogan D, Karaman A, Cakmak O. Comparison of closed‐tube thoracostomy and open thoracotomy procedures in the management of thoracic empyema in childhood. European Journal of Pediatric Surgery 2004;14(4):250‐4. CENTRAL

Kurt 2006 {published data only}

Kurt BA, Winterhalter KM, Connors RH, Betz BW, Winters JW. Therapy of parapneumonic effusions in children: video‐assisted thoracoscopic surgery versus conventional thoracostomy drainage. Pediatrics 2006;118(3):e547‐53. CENTRAL

Marhuenda 2014 {published data only}

Marhuenda C, Barceló C, Fuentes I, Guillén G, Cano I, López M, et al. Urokinase vs VATS for treatment of empyema: A randomised multicenter clinical trial. Pediatrics 2014;134(5):e1300. CENTRAL

Peter 2009 {published data only}

Peter SD, Tsao K, Spilde TL, Keckler SJ, Harrison C, Jackson MA, et al. Thoracoscopic decortication vs tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial. Journal of Pediatric Surgery 2009;44(1):106‐11. CENTRAL

Sonnappa 2006 {published data only}

Sonnappa S, Cohen G, Owens CM, van Doorn C, Cairns J, Stanojevic S, et al. Comparison of urokinase and video‐assisted thoracoscopic surgery for treatment of childhood empyema. American Journal of Respiratory & Critical Care Medicine 2006;174(2):221‐7. CENTRAL

Wait 1997 {published data only}

Wait MA, Sharma S, Hohn J, Dal Nogare A. A randomised trial of empyema therapy. Chest 1997;111(6):1548‐51. CENTRAL

Angelillo 1996 {published data only}

Angelillo Mackinlay TA, Lyons GA, Chimondeguy DJ, Piedras MA, Angaramo G, Emery J. VATS debridement versus thoracotomy in the treatment of loculated postpneumonia empyema. Annals of Thoracic Surgery 1996;61(6):1626‐30. CENTRAL

Bagheri 2013 {published data only}

Bagheri R, Tavassoli A, Haghi SZ, Attaran D, Sadrizadeh A, Asnaashari A, et al. The role of thoracoscopic debridement in the treatment of parapneumonic empyema. Asian Cardiovascular & Thoracic Annals Aug 2013;21(4):443‐6. CENTRAL

Bouros 1997 {published data only}

Bouros D, Schiza S, Patsourakis G, Chalkiadakis G, Panagou P, Siafakas NM. Intrapleural streptokinase versus urokinase in the treatment of complicated parapneumonic effusions: a prospective, double‐blind study. American Journal of Respiratory & Critical Care Medicine 1997;155(1):291‐5. CENTRAL

Bouros 1999 {published data only}

Bouros D, Schiza S, Tzanakis N, Chalkiadakis G, Drositis J, Siafakas N. Intrapleural urokinase versus normal saline in the treatment of complicated parapneumonic effusions and empyema. A randomized, double‐blind study. American Journal of Respiratory & Critical Care Medicine 1999;159(1):37‐42. CENTRAL

Chin 1997 {published data only}

Chin NK, Lim TK. Controlled trial of intrapleural streptokinase in the treatment of pleural empyema and complicated parapneumonic effusions. Chest 1997;111(2):275‐9. CENTRAL

Cho 2000 {published data only}

Cho CH, Kwak SM, Park CS, Bae IY, Moon TH, Cho JH, et al. The effects of urokinase instillation therapy via percutaneous transthoracic catheter drainage in loculated pleural effusion: a randomised prospective study. European Respiratory Journal 2000;16(31):579. CENTRAL

Davies 1997 {published data only}

Davies RJ, Traill ZC, Gleeson FV. Randomised controlled trial of intrapleural streptokinase in community acquired pleural infection. Thorax 1997;52(5):416‐21. CENTRAL

Diacon 2004 {published data only}

Diacon AH, Theron J, Schuumans MM, Van de Wal BW, Bolliger CT. Intrapleural streptokinase for empyema and complicated parapneumonic effusions. American Journal of Respiratory & Critical Care Medicine 2004;170(1):49‐53. CENTRAL

Hewidy 2014 {published data only}

Hewidy A, Elshafey M. Medical thoracoscopy versus intrapleural fibrinolytic therapy in complicated parapneumonic effusion and empyema. Egyptian Journal of Chest Diseases and Tuberculosis 2014;63(4):896‐9. CENTRAL

Lin 2011 {published data only}

Lin JC, Zhang CR, Xu WM, Li M, Cui WL. Effectiveness and safety of intrapleural tissue plasminogen activator in the prevention of pleural thickening and loculated effusions by infective pleurisy. International Journal of Infectious Diseases 2011;15(Suppl):104‐5. CENTRAL

Maskell 2005 {published data only}

Maskell NA, Davies CW, Nunn AJ, Hedley EL, Gleeson FV, Miller R, et al. UK controlled trial of intrapleural streptokinase for pleural infection. New England Journal of Medicine 2005;352(9):865‐74. CENTRAL

Mathew 2015 {published data only}

Mathew JL, Lodha R, Sharma S. VATS or urokinase for treatment of empyema?. Indian Pediatrics 2015;52(1):57‐60. CENTRAL

Minchev 2004 {published data only}

Minchev TS, Dzhambazov V, Petrov D, Stanoev V, Aleksov S, Petkov R. Video‐assisted thoracoscopic surgery (VATS) for treatment of pleural empyema [Video‐asistirana torakoskopska khirurgiia (VATS) za lechenie na plevralniia empiem]. Khirurgiia 2004;60(2):15‐7. CENTRAL

Misthos 2005 {published data only}

Misthos P, Sepsas E, Konstantinou M, Athanassiadi K, Skottis L, Lioulias A. Early use of intrapleural fibrinolytics in the management of postpneumonic empyema. A prospective study. European Journal of Cardio‐Thoracic Surgery 2005;28(4):599‐603. CENTRAL

Nandeesh 2013 {published data only}

Nandeesh M, Sharathchandra BJ, Thrishuli PB. ICD versus VATS as primary treatment in fibrinopurulent stage of empyema thoracis. Journal of Clinical and Diagnostic Research 2013;7(12):2855‐8. CENTRAL

Rahman 2009 {published data only}

Rahman NM, Maskell N, Davies CW, West A, Teoh R, Arnold A, et al. Primary result of the Second Multicentre Intrapleural Sepsis (MIST2) trial; randomised trial of intrapleural TPA and DNase in pleural infection. Thorax 2009;64:A1. CENTRAL

Rahman 2011 {published data only}

Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, et al. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. New England Journal of Medicine 2011;365(6):518‐26. CENTRAL

Sahn 1998 {published data only}

Sahn SA. Use of fibrinolytic agents in the management of complicated parapneumonic effusions and empyemas. Thorax 1998;53(Suppl):65‐72. CENTRAL

Shah 2006 {published data only}

Shah NN, Bachh AA, Bhargava R, Ahmad Z, Panday DK, Shameem M. Role of intrapleural streptokinase in management of multiloculated thoracic empyemas. JK Practitioner 2006;13(2):91‐4. CENTRAL

Singh 2004 {published data only}

Singh M, Mathew JL, Chandra S, Katariya S, Kumar L. Randomized controlled trial of intrapleural streptokinase in empyema thoracis in children. Acta Paediatrica 2004;93(11):1443‐5. CENTRAL

Talib 2003 {published data only}

Talib SH, Verma GR, Arshad M, Tayade BO, Rafeeque A. Utility of intrapleural streptokinase in management of chronic empyemas. Journal of the Association of Physicians of India 2003;51:464‐8. CENTRAL

Thommi 2012 {published data only}

Thommi G, Shehan JC, Robison KL, Christensen M, Backmeyer LA, McLeay MT. A double blind randomized cross over trial comparing rate of decortication and efficacy of intrapleural instillation of alteplase vs placebo in patients with empyemas and complicated parapneumonic effusions. Respiratory Medicine 2012;106(5):716‐23. CENTRAL

Thomson 2002 {published data only}

Thomson AH, Hull J, Kumar MR, Wallis C, Balfour Lynn IM. Randomised trial of intrapleural urokinase in the treatment of childhood empyema. Thorax 2002;57(4):343‐7. CENTRAL

References to studies awaiting assessment

Ahmed 2016 {published data only}

Ahmed S, Azam H, Basheer I. Is open decortication superior to fibrinolytic therapy as a first line treatment in the management of pleural empyema?. Pakistan Journal of Medical Sciences 2016;32(2):329‐32. CENTRAL

Hasimoto 2015 {published data only (unpublished sought but not used)}

Hasimoto EN, Hasimoto FN, Cataneo DC, Cataneo AJM. Pleural empyema treatment in children: Simple pleural drainage or videothoracoscopy? A controlled clinical trial. Interactive Cardiovascular and Thoracic Surgery 2015;21(Suppl 1):59‐510. CENTRAL

NCT00234208 {published and unpublished data}

NCT00234208. Early medical thoracoscopy versus simple chest tube drainage in complicated parapneumonic effusion and pleural empyema. clinicaltrials.gov/ct2/show/NCT00234208?term=empyema&rank=1 (first received 5 October 2005). CENTRAL

Zhang 2011 {published data only}

Zhang J, Liu J, Li Y, Huang SH, Chen HG, Wang CP, et al. Video‐assisted thoracic surgery (VATS) is superior to chest tube drainage in fibropurulent empyema. International Journal of Infectious Diseases 2011;15(Suppl 1):51‐2. CENTRAL

Atkins 2004

Atkins D, Best D, Briss PA, Eccles M, Falck‐Ytter Y, Flottorp S, et al. GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.

Aye 1991

Aye RW,  Froese DP,  Hill LD. Use of purified streptokinase in empyema and hemothorax. American Journal of Surgery 1991;161(5):560‐2.

Balfour‐Lynn 2005

Balfour‐Lynn IM, Abrahamson E, Cohen G, Hartley J, King S, Parikh D, et al. British Thoracic Society: Guidelines for the management of pleural infection in children. Thorax 2005;60(Suppl 1):1‐21.

Cameron 2008

Cameron R,  Davies HR. Intra‐pleural fibrinolytic therapy versus conservative management in the treatment of adult parapneumonic effusions and empyema. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD002312.pub3]

Chapman 2004

Chapman SJ,  Davies RJ. The management of pleural space infections. Respirology 2004;9(1):4‐11.

Davies 2010

Davies HE, Davies RJO, Davies CWH. Management of pleural infection in adults: British Thoracic Society pleural disease guideline 2010. Thorax 2010;65:45‐53.

Ferguson 1996

Ferguson AD, Prescott RJ, Selkon JB, Watson D, Swinburn CR. The clinical course and management of thoracic empyema. Quarterly Journal of Medicine 1996;89:285‐9.

GRADEpro GDT 2015 [Computer program]

GRADEpro GDT. GRADEpro Guideline Development Tool [www.guidelinedevelopment.org]. Hamilton: McMaster University (developed by Evidence Prime, Inc.), 2015.

Higgins 2011

Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.handbook.cochrane.org.

Jaffé 2003

Jaffé A, Cohen G. Thoracic empyema. Archives of Disease in Childhood 2003;88:839‐41.

Jones 2003

Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YCG, Light RW. Ultrasound‐guided thoracentesis. Is it a safer method?. Chest 2003;123(2):418‐23.

Kaifi 2012

Kaifi JT,  Toth JW,  Gusani NJ,  Kimchi ET,  Staveley‐O'Carroll KF, Belani CP,  et al. Multidisciplinary management of malignant pleural effusion. Journal of Surgical Oncology 2012;105(7):731‐8.

Krenke 2010

Krenke K, Peradzynska J, Lange J, Ruszczynski M, Kulus M, Szajewska H. Local treatment of empyema in children: a systematic review of randomized controlled trials. Acta Paediatrica 2010;99(10):1449‐53.

Kundu 2010

Kundu S,  Mitra S,  Mukherjee S,  Das S. Adult thoracic empyema: a comparative analysis of tuberculous and nontuberculous etiology in 75 patients. Lung India 2010;27(4):196‐201.

Lardinois 2005

Lardinois D, Gock M, Pezzetta E, Buchli C, Rousson V, Furrer M, et al. Delayed referral and gram‐negative organisms increase the conversion thoracotomy rate in patients undergoing video‐assisted thoracoscopic surgery for empyema. Annals of Thoracic Surgery 2005;79(6):1851‐6.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

Light 1985

Light RW. Parapneumonic effusions and empyema.. Clinical Chest Medicine 1985;6(1):55‐62.

Light 2006

Light RW. Parapneumonic effusions and empyema. Proceedings of the American Thoracic Society 2006;3:75‐80.

Marshall 2009

Marshal JC, Naqbi AA. Principles of Source Control in the Management of Sepsis. Critical Care Clinics 2009;35(4):753‐68.

Miller 1987

Miller KS, Sahn SA. Chest tubes. Indications, technique, management and complications. Chest 1987;91:258‐64.

Oddel 1994

Oddel J. Management of empyema thoracis. Journal of the Royal Society of Medicine 1994;87:466‐71.

RevMan 2014 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Sahn 2007

Sahn SA. Diagnosis and management of parapneumonic effusions and empyema. Clinical Infectious Diseases 2007;45(11):1480‐6.

Temes 1996

Temes RT,  Follis F,  Kessler RM,  Pett SB,  Wernly JA. Intrapleural fibrinolytics in management of empyema thoracis. Chest 1996;110(1):102‐6.

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Tillett WS,  Sherry S,  Read CT. The use of streptokinase‐streptodornase in the treatment of chronic empyema; with an interpretive discussion of enzymatic actions in the field of intrathoracic diseases. Journal of Thoracic Surgery 1951;21(4):325‐41.

Yim 1996

Yim A, Liu H. Complications and failures of video‐assisted thoracic surgery: experience from two centers in Asia. Annals of Thoracic Surgery 1996;61:538‐41.

References to other published versions of this review

Chin 2013

Chin TY, Redden MD, Hsu CCT, van Driel ML. Surgical versus non‐surgical management for pleural empyema. Cochrane Database of Systematic Reviews 2013, Issue 7. [DOI: 10.1002/14651858.CD010651]

Coote 2005

Coote N,  Kay E. Surgical versus non‐surgical management of pleural empyema. Cochrane Database of Systematic Reviews 2005, Issue 4. [DOI: 10.1002/14651858.CD001956.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Bilgin 2006

Methods

Parallel randomised controlled clinical trial

Randomisation ratio: 1:1

Country: Turkey

Number of study centres: 1

Participants

N recruited = 70

N randomised = 70

N reported outcomes = 70

Mean age = 47.35 years

Gender (m/f) = 59/11

N tube thoracostomy = 35

N VATS = 35

Inclusion criteria:

Diagnosis of empyema by:

  • chest radiograph or CT scan;

  • pleural fluid pH, LDH, glucose and microbiological examination.

Required values for pleural fluid measurements not given.

Exclusion criteria: not reported

Interventions

Treatment before study: not reported

Titration period and treatment:

  • After diagnosis patients were randomised to receive either conventional thoracostomy or VATS (with fibrin debridement and saline irrigation) with subsequent thoracostomy.

  • For both groups, pleural decortication by thoracotomy was performed if there was evidence of pleural thickening (with or without trapped lung), loculated empyema, or bronchopleural fistula.

  • Antibiotic therapy was continued for at least 7 days (details not reported).

Outcomes

Time of outcome measurements: not reported

Primary outcome(s):

  • Length of hospital stay

    • 8.3 (7 to 11) days (VATS) versus 12.8 (10 to 18) days (thoracostomy)

  • Need for pleural decortication by open thoracotomy

    • 6/35 (VATS) versus 13/35 (thoracostomy)

Secondary outcome(s): Outcomes not divided into primary and secondary.

Other outcome(s): not reported

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Type of funding: not reported

Conflicts of interest: none reported

Stated aim for study: "We studied whether insertion of a chest tube by initially using video‐assisted thoracoscopy (VAT) results in shortening of hospitalisation time and reduces the necessity of open decortication."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Low risk

Closed‐envelope method

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

Cobanoglu 2011

Methods

Parellel randomised controlled trial

Randomisation ratio: 1:1

Superiority design

Country: Turkey

Number of study centres: 1

Participants

N recruited = 54

N randomised = 54 (Stage II = 23, Stage III = 31)

N reported outcomes = 54

Mean age = 8.02 years

Gender (m/f) = 32/22

N fibrinolytics = 27

N VATS = 27

Inclusion criteria:

(Children's study, however maximum age not stated.)

  • Pleural fluid pH < 7.2

  • Pleural fluid glucose < 60 mg/dL

  • Pleural fluid protein > 3 g/dL

  • Pleural fluid LDH > 1000 IU

  • Pleural fluid leukocytes > 5 x 10^9/L

  • Presence of bacteria on direct examination of pleural fluid

Exclusion criteria:

  • Contraindications to fibrinolysis or thoracoscopic intervention

  • Immunosuppression

  • Additional infection foci

  • Bronchopleural fistula

  • Those with other simultaneous diseases

  • Stage I pleural empyema (did not meet the inclusion criteria)

Interventions

Treatment before study:

Pre‐hospital: 76% nil, remainder had irregular antibiotics

After diagnosis: All received empiric treatment of ampicillin sulbactam plus cefotaxime, and an 18 to 24 Fr chest tube was inserted in all cases and connected to a closed drainage system with negative suction.

Titration period and treatment: After diagnosis, participants received either STK or VATS

VATS: After procedure, chest tube was left in place. 6 participants required conversion to mini‐thoracotomy.

STK: Normal saline with 250,000 U/100 mL STK was administered into the pleural cavity through the chest tube in 70‐ to 120‐mL volume once a day, and the tube was held by a clamp for 4 to 6 hours. The period of fibrinolytic treatment was determined as 4.45 days (3 to 5 days). 8 participants required further VATS.

Common: Chest tube removed when daily drainage less than 50 mL and radiological healing and full expansion detected.

Outcomes

Primary outcome(s): Success was based on whether further intervention was required.

Lung was fully expanded and the procedure was considered successful:

STK: 19 of 27 cases (70.37%) versus VATS: 21 cases of 27 (77.77%)

(P = 0.533)

Secondary outcome(s):

  • Post‐therapy days of oxygen requirement: STK (2.3) versus VATS (2.1)

  • Afebrile days after intervention: STK (3.9) versus VATS (3.4)

  • Analgesia: STK (22.1) versus VATS (25.4)

  • Chest tube removal time: STK (9.48) versus VATS (6.56); P < 0.05

  • LOS: STK (10.37) versus VATS (7.41); P < 0.05

  • Duration of symptoms: STK (6.78) versus VATS (3.78)

  • Cost: STK (USD 386.672) versus VATS (USD 957.487); P < 0.05

  • Fluid drainage

  • Respiratory function tests

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "The aim of this study was to prospectively compare thoracoscopic debridement and fibrinolytic treatment in cases with stage II and III empyema and to present a perspective for treatment options."

Funding: not disclosed

Conflicts of interest: not disclosed

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible given the nature of the study.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

The following statement might indicate potential selection bias, however, based on data in the paper, it is unclear if any participants were excluded from the fibrinolytics group after randomisation:

"Patients with hemorrhagic diathesis, stroke or manifest haemorrhage having occurred in the previous six months and those who had used fibrinolytic agents for any reason in the previous two years were excluded from the fibrinolytic treatment group."

Funding source not reported.

Karaman 2004

Methods

Parallel randomised controlled clinical trial

Randomisation ratio: 1:1

Number of study centres: 1

Participants

N recruited = 30

N randomised = 30

N reported outcomes = 30

Mean age = 3.9 years (study in children)

Gender m/f = 15/15

N tube thoracostomy = 15

N open thoracotomy = 15

Inclusion criteria:

Patients with pleural empyema confirmed by:

  • chest X‐ray;

  • ultrasound;

  • pleural fluid pH, glucose, protein, gram stain, direct microscopy, and culture.

Required values for pleural fluid measurements not given.

Exclusion criteria:

  • Patients with stage I and stage III pleural empyema. Staging criteria not given (most likely American Thoracic Society).

  • Immunodeficiency

  • Tuberculosis

  • Malignancy

Interventions

Treatment before study: 80% of participants had been treated with antibiotics for periods ranging from 2 to 20 days prior to admission (mean 4.7 days). 4 of these participants were treated in another centre for pneumonia and were given 2nd‐ or 3rd‐generation cephalosporins and aminoglycosides. The other participants were treated with beta‐lactams.

Titration period and treatment:

  • After diagnosis, participants were randomised to receive either closed‐tube thoracostomy or open thoracotomy (with adhesiolysis, debridement, irrigation, and suturing of bronchopleural fistulas) with subsequent tube thoracostomy.

  • All participants were given antibiotics (sulbactam/ampicillin + aminoglycosides). 10 were switched to vancomycin, cefoperazone, or ceftriaxone depending upon participant’s clinical condition and culture results.

  • Chest tubes were removed when the participant's body temperature was normal and chest tube drainage reduced to < 30 mL/day with no purulent characteristics.

  • No treatment algorithm was given with regard to failure of either treatment.

Outcomes

Time of outcome measurements: not reported

Primary outcome(s):

  • Duration of chest tube drainage

    • 7.5 ± 1.1 days (thoracotomy group) versus 13.8 ± 2.3 days (thoracostomy group)

  • Length of hospital stay

    • 9.5 ± 1.5 days (thoracotomy group) versus 15.4 ± 2.3 days (thoracostomy group)

  • Duration of fever

    • In the thoracotomy group, 60% returned to normal body temperature within 24 hours; 13.3% between 25 to 48 hours; and 26.7% between 49 to 72 hours.

    • In the thoracostomy group, 26.7% returned to normal body temperature within 24 hours; 13.3% between 25 to 48 hours; and 60% between 49 to 72 hours.

  • Time to respiratory recovery

    • In the thoracotomy group, 40% returned to normal respiratory rate within 24 hours; 26.7% between 25 to 48 hours; and 33.3% between 49 to 72 hours.

    • In the thoracostomy group, 13.3% returned to normal respiratory rate within 24 hours; 6.7% between 25 to 48 hours; and 80% between 49 to 72 hours.

Secondary outcome(s): Outcomes not divided into primary and secondary.

Other outcome(s): In both groups, duration of chest tube drainage was found to be longer in participants whose pleural fluid pH was < 7.2.

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Type of funding: not reported

Conflicts of interest: none reported

Stated aim for study: "The aim of this study is to compare the effectiveness of closed‐tube thoracostomy and open thoracotomy procedures in the management of empyema in children."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not mentioned

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible given the nature of the study.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

Kurt 2006

Methods

Parallel randomised controlled clinical trial

Randomisation ratio: VATS:thoracostomy = 10:8

Country: USA

Number of study centres: 1

Participants

N recruited = 18

N randomised = 18

N reported outcomes = 18

Mean age = 64.5 months (study in children)

Gender m/f = 10/8

N tube thoracostomy = 8

N VATS = 10

Inclusion criteria:

  • 0 to 18 years of age

  • Evidence of community‐acquired pneumonia with parapneumonic effusion

  • Effusion greater than 1.5 cm (widest pleura‐pleura collection on CT scan)

  • Clinically judged to require evacuation (fever, tachypnoea, persistent chest or abdominal pain, or leukocytosis)

Exclusion criteria:

  • Hospital‐acquired pneumonia

  • Previous drainage procedure

  • Uncorrected cardiac disease

  • Known immunocompromise

  • Pre‐existing bronchopleural fistula

  • Contraindications to fibrinolytic therapy

  • Suspected non‐bacterial infection

Interventions

Treatment before study: All participants had received antibiotic therapy that was appropriate for the suspected micro‐organisms prior to enrolment.

Titration period and treatment:

  • After diagnosis, participants were randomised to receive either conventional thoracostomy or VATS (with dissection of loculations and debridement) with subsequent tube thoracostomy.

  • For participants in the thoracostomy group, a follow‐up chest X‐ray was performed within 24 hours of tube placement. If significant clearance of the collection was seen, then the tube was left in place until it drained < 1 mL/kg/day for > 24 hours. If significant clearance was not seen, then fibrinolytic therapy (reteplase) was commenced. Reteplase (1/50 mL normal saline) was administered through the chest tube. The dose given was 1 mL/kg with a minimum dose of 25 mL and a maximum dose of 100 mL 4 times a day. Reteplase was continued for as long as drainage remained above 1 mL/kg/day for a maximum of 5 days. If the drainage remained > 1 mL/kg/day after 5 days, a CT‐guided pigtail catheter was placed and fibrinolytic therapy given. If the effusion persisted after pigtail catheter placement, the participant was then evaluated to receive either VATS or open thoracotomy.

  • For participants in the VATS group, the chest drain remained in place until drainage was < 1 mL/kg/day and there was resolution of the effusion. If the effusion persisted, then a similar protocol to the thoracostomy group was followed with fibrinolytic therapy, pigtail catheter placement, and repeat VATS/thoracotomy.

Outcomes

Time of outcome measurements: not reported

Primary outcome(s):

  • Length of hospital stay

    • 5.80 ± 2.82 days (VATS) versus 13.25 ± 7.15 days (thoracostomy); P = 0.004

  • Duration of chest tube drainage

    • 2.80 ± 0.63 days (VATS) versus 9.63 ± 5.45 days (thoracostomy); P < 0.001

Secondary outcome(s):

  • Fever duration

    • 3.60 ± 2.95 days (VATS) versus 6.25 ± 4.10 days (thoracostomy); P = 0.145

  • Days of oxygen use

    • 1.60 ± 1.26 days (VATS) versus 3.63 ± 5.71 days (thoracostomy); P = 0.965

  • Days of narcotic use

    • 2.20 ± 1.48 days (VATS) versus 7.63 ± 6.32 days (thoracostomy); P = 0.043

  • Number of chest radiographs

    • 8.10 ± 2.33 (VATS) versus 16.75 ± 9.90 (thoracostomy); P = 0.016

  • Number of chest CT scans

    • 1.0 ± 0.0 (VATS) versus 3.13 ± 1.25 (thoracostomy); P < 0.001

  • Number of drainage procedures

    • 1.0 ± 0.0 (VATS) versus 2.25 ± 1.91 (thoracostomy); P = 0.002

  • Procedure time

    • 47.44 ± 14.59 minutes (VATS) versus 30.00 ± 6.93 minutes (thoracostomy); P = 0.016

  • Sedation time

    • 86.20 ± 17.42 minutes (VATS) versus 80.63 ± 28.96 minutes (thoracostomy); P = 0.460

  • Need for fibrinolysis

    • 0 (VATS) versus 2.63 ± 2.07 days (thoracostomy); P = 0.001

Other outcome(s):

  • Facility charges

    • USD 12,988 (10,799 to 15,606) (VATS) versus USD 18,447 (13,931 to 29,562) (thoracostomy); P = 0.016

  • Physician charges

    • USD 6668 (5634 to 7291) (VATS) versus USD 4414 (3718 to 7896) (thoracostomy); P = 0.146

  • Total charges

    • USD 19,714 (17,325 to 23,000) (VATS) versus USD 21,947 (17,895 to 37,458) (thoracostomy); P = 0.004

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Type of funding: not reported

Conflicts of interest: none reported

Stated aim for study: "This trial of paediatric patients with community‐acquired pneumonia and associated parapneumonic processes compared primary video‐assisted thoracoscopic surgery with conventional thoracostomy drainage."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Using a random number method in groups of 10 generated by a Spectrum Health research nurse"

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

Marhuenda 2014

Methods

Parellel randomised controlled trial

Randomisation ratio: 1:1

Number of study centres: 6

Participants

N recruited = 149

N randomised = 105

N reported outcomes = 103

Mean age = VATS 4.14 years; urokinase 4.63 years

Gender m/f = 61/42

N Urokinase = 50

N VATS = 53

Inclusion criteria:

  • Aged under 15 years old

  • Previously healthy

  • Community‐acquired pneumonia and parapneumonic pleural effusion with any one of the following.

    • Sonographic features of complicated effusion

    • Fever and ultrasound‐proven complicated effusion

    • Effusion more than 1 cm and fever of above 38°C after 24 hours of appropriate intravenous antibiotic treatment

    • Tachypnoea

    • Oxygen requirement as a consequence of the effusion

    • Increase in the size of the effusion during the observation period

Exclusion criteria:

  • Anechoic, non‐septated effusion

  • Pre‐existing conditions

  • Cerebral paralysis

  • Congenital cardiopathy

  • Previous cardiac or thoracic surgery in the affected hemithorax

  • Immunodeficiency

  • Significant thoracic trauma in the last 2 months

  • Thrombocytopenia or abnormal clotting

  • Severe arterial hypertension

  • Tuberculous empyema

  • Pneumothorax before treatment

  • Patients treated with chest tube placement at the referring hospital

Interventions

Treatment before study: none reported

Titration period and treatment: After diagnosis, participants were randomly allocated to either the VATS debridement group or the urokinase instillation group.

VATS: The procedure was carried out by or under direct supervision of a senior surgeon. 1 or 2 chest tubes were left in place after the procedure.

Urokinase: 12Fr to 14Fr chest tubes were used with insertion site selected using sonography. The pleural fluid was first drained, then urokinase was instilled into the pleural cavity through the tube. 10 mL of a 1000 IU/mL solution of urokinase in children aged 1 year and 40 mL in older children was administered every 12 hours for 3 days. After instillation, the chest tube was clamped for 4 hours. It was then unclamped and connected to a suction system at –20 cm H₂O for 8 hours.

Common:

  • For both procedures, chest tubes were removed when the drainage volume was 40 to 60 mL/24 hours.

  • Antibiotic treatment recommendations were not included in the study protocol. It was assumed that participants would receive empiric treatment with antibiotics covering the spectrum of the most common micro‐organisms in our setting, with subsequent treatment adjustment based on microbiology results. After removal of the chest tube, antibiotic treatment could be administered orally, provided that the participant had been afebrile (< 37.5°C) for 24 hours. Participants could be discharged if they had been afebrile for at least 24 hours with oral treatment. Persistent fever (> 38°C) for 4 days after either of the study treatments, associated with persistent purulent pleural collections on ultrasound, was considered treatment failure.

Outcomes

Primary outcome(s):

  • Postoperative hospital stay, median (IQR) days: VATS 10 (7 to 13) versus urokinase 9 (8 to 12); P = 0.45

Secondary outcome(s):

  • Total hospital stay, median (IQR) days: VATS 14 (10 to 16) versus urokinase 13 (10 to 18); P = 0.6

  • Chest tube in place, median (IQR) days: VATS 4 (3 to 5) versus urokinase 5 (4 to 6); P < 0.001

  • Postoperative fever, median (IQR) days: VATS 4 (2 to 7) versus urokinase 6 (3 to 7); P = 0.62

  • Failure rate, n (%): VATS 8 (15.1%) versus urokinase 5 (10%); P = 0.47

Other outcome(s):

At 3 months:

n = VATS (36 (67.9%)) versus urokinase (42 (84%))

Of those, normal X‐ray or only small changes: VATS (66.7%) versus urokinase (59.5%); P = 0.4

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "The aim of this study was to compare the efficacy of drainage plus urokinase versus video‐assisted thoracoscopic surgery in the treatment of PPE in childhood."

Funding: Institute of Health Carlos III, under the Spanish Ministry of Science and Innovation

Conflicts of interest: 2 of the authors (Moreno‐Galdo, Perez‐Yarza) are advisory board members of AbbVie Inc, and have received funding from several pharmaceutical companies for travel to conferences and fees for speaking.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomisation sequence, stratified according to centre and with varying block sizes to ensure balance in both groups

Allocation concealment (selection bias)

Low risk

"The attending physician accessed a Web platform and obtained the treatment assigned to each new patient," after consent had been signed.

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible given the nature of the study.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Loss of participants to 3‐month follow‐up, but this would not have affected any of the primary or secondary outcomes.

Selective reporting (reporting bias)

Low risk

All outcomes published in protocol on ClinicalTrials.gov were included in the results.

Other bias

Unclear risk

2 authors (Moreno‐Galdo, Perez‐Yarza) are advisory board members of AbbVie Inc, and have received funding from several pharmaceutical companies for travel to conferences and fees for speaking.

Peter 2009

Methods

Parellel randomised controlled trial

Randomisation ratio: 1:1

Superiority design

Number of study centres: 1

Country: USA

Participants

N recruited = 36

N randomised = 36

N reported outcomes = 36

Mean age = 5 years

Gender = not reported

N tPA = 18

N VATS = 18

Inclusion criteria:

Only patients under 18 years of age were included.

Diagnosis of empyema:

  • septations or loculations in pleural space on CT or ultrasound; or

  • purulent tap with WCC > 10,000 cells/uL

Exclusion criteria:

  • Contraindication to either fibrinolytic agent or thoracoscopy

  • Additional foci of infection

  • Immunosuppression

  • Comorbid conditions that would extend hospital stay beyond course of empyema

Interventions

Titration period and treatment:

VATS: Performed by 1 of 5 staff surgeons. Chest drain left in place post procedure.

tPA: 12Fr chest tube inserted and drained with suction. Fibrinolysis was performed by mixing 4 mg of tPA into 40 mL of sterile normal saline. Tube clamped for 1 hr before continuing suction. This was done once on tube insertion and 2 additional doses each at 24 hrs.

Common:

Clindamycin (10 mg/kg/dose) every 6 hours and ceftriaxone (25 mg/kg per dose) every 12 hours. If haemodynamic instability existed (hypotension, need for vasoactive medications, or persistent tachycardia), then vancomycin (15 mg/kg per dose) every 6 hours was added. Antibiotic therapy was tailored toward positive culture results and the individual patient’s course.

Tubes removed when no air leakage and drainage output was < 1 mL/kg per day calculated for the previous 12 hours.

Outcomes

At diagnosis, there were no differences between groups in age, weight, degree of oxygen support, white blood cell count, or days of symptoms.

No difference in LOS after intervention, days of oxygen requirement, days until afebrile, or analgesic requirements

VATS higher cost.

3 in tPA group required VATS.

1 in VATS group required ventilator, 1 required ventilator and temporary dialysis

Primary outcome(s):

  • LOS: tPA (6.8) versus VATS (6.9)

  • Post‐therapy days with oxygen requirement: tPA (2.3) versus VATS (2.3)

  • Afebrile days after intervention: tPA (3.8) versus VATS (3.1)

  • Analgesia: tPA (21.4) versus VATS (22.3)

  • Hospital charges: tPA (USD 7600) versus VATS (USD 11,700); P < 0.05

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "we conducted a prospective, randomised trial comparing VATS to fibrinolytic therapy in children with empyema."

Funding: not disclosed

Conflicts of interest: not disclosed

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Computer generated using an individual unit of randomization in an unstratified sequence in blocks of 4"

Allocation concealment (selection bias)

Low risk

"The randomization sequence was accessed to identify the next allotment after the consent form was signed"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

Sonnappa 2006

Methods

Parallel randomised controlled trial

Randomisation ratio: 1:1

Superiority design

Number of study centres: 1

Country: UK

Participants

N recruited = 60

N randomised = 60

N reported outcomes = 60

Median age = VATS 3.57 years; urokinase 3.07 years

Gender m/f = 33/27

N Urokinase = 30

N VATS = 30

Inclusion criteria:

  • Aged under 16 years

  • Radiographic evidence of empyema

  • Indications for drainage (persistent fever of > 38°C after 24 hrs of intravenous antibiotics, respiratory distress caused by pleural collection)

Exclusion criteria:

  • Thoracocentesis or chest tube performed or attempted at referring hospital

  • Underlying cardiac disease

  • Previous cardiac surgery

  • Immunodeficiency

Interventions

Treatment before study: none reported

Titration period and treatment:

VATS: After the procedure, 1 or 2 chest drains were placed in the portholes on negative suction pressure.

4 children required conversion to mini‐thoracotomy.

Urokinase: Pleural fluid was allowed to drain out first, after which intrapleural urokinase was instilled every 12 hours for 3 days, in a dose of 10,000 U in 10 mL normal saline in children under 1 yr of age and 40,000 U in 40 mL normal saline in children above 1 yr of age.

5 children required conversion to VATS.

Common: Chest drains were removed when there was minimal drainage (40 to 60 mL/24 hours), and children were discharged home if they remained afebrile for 24 hours after drain removal and at the attending paediatrician's discretion.

Outcomes

Ultrasound staging at entry:

Stage I: VATS (6) versus Uro (10)

Stage II: VATS (13) versus Uro (8)

Stage III: VATS (11) versus Uro (12)

Primary outcome(s):

  • LOS after intervention: VATS (6 (3 to 16) days) versus Uro (6 (4 to 25) days) (P = 0.311)

  • Total LOS: VATS (8 (4 to 17) days) versus Uro (7 (4 to 25) days) (P = 0.645)

  • Failure rate: VATS (4 required mini‐thoracotomy, 1 required 2nd VATS) versus Uro (2 required VATS)

Secondary outcome(s):

  • Number of days chest drain: 1 day less in VATS group (P = 0.055)

  • Cost: Uro (USD 9127) versus VATS (USD 11,379) (P < 0.001)

  • Post‐therapy days with oxygen requirement: Uro (12) versus VATS (12)

  • Afebrile days after intervention: Uro (2.5) versus VATS (2.5)

At 6 months:

16 lost to follow‐up

Chest X‐ray on 24 VATS and 20 Uro

"Abnormal chest x‐ray" VATS 21 versus Uro 18

Stage I: VATS had a reduced hospital stay of borderline statistical significance: VATS (5 (3 to 5) days) versus Uro (6 (4 to 25) days) (P = 0.056). However, there was an outlier of 25 days in the urokinase group.

No difference in Stage II or III

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "Our study is the first randomised prospective trial to compare chest drain with intrapleural urokinase against primary VATS for the treatment of empyema in children."

Funding: not disclosed

Conflicts of interest:"None of the authors has a financial relationship with a commercial entity that has an interest in the subject of this manuscript."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The randomization scheme was generated by using the internet web site http://www.randomization.com"

Allocation concealment (selection bias)

Low risk

"The trial coordinator was contacted by telephone to reveal treatment allocation"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible given the nature of the study.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Loss of patients to 6‐month chest radiograph would not influence any other outcome measure.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

Wait 1997

Methods

Parallel randomised controlled clinical trial

Randomisation ratio: VATS:thoracostomy = 11:9

Number of study centres: 1

Participants

N recruited = 20

N randomised = 20

N reported outcomes = 20

Mean age = 42.45 years

Gender m/f = 15/5
N tube thoracostomy + streptokinase = 9

N VATS = 11

Inclusion criteria:

  • Signs and symptoms of bacterial pneumonia and pleural effusion (temp > 38, blood WCC > 11,000/mm³, purulent sputum, pleuritic chest pain, and a radiographic infiltrate)

  • Loculated pleural effusion (on imaging) or pleural fluid pH ≤ 7.2

  • 18 years of age or older

  • Ability to undergo general anaesthesia

  • No allergies to anaesthetic or streptokinase

  • No rapidly fatal underlying illness

  • Ability to tolerate single lung ventilation

Exclusion criteria: not reported

Interventions

Treatment before study: not reported

Titration period and treatment:

  • After diagnosis, participants were randomised to receive thoracostomy with streptokinase therapy or VATS (with debridement of fibrin/loculation and irrigation with antibiotic solution) with subsequent tube thoracostomy.

  • Participants treated with streptokinase were given 250,000 U of streptokinase in 100 mL normal saline through the chest tube. The chest tube was clamped for 4 hours then unclamped and allowed to drain. This was repeated every 24 hours until 3 instillations had been completed.

  • Chest tubes remained in place until drainage was < 100 mL/day.

  • Participants in both groups were given antibiotics chosen to cover the likely pathogens. These were later adjusted based on the results of bacterial cultures.

  • For participants in the thoracostomy group, failure of therapy at 72 h was indicated by: ≥ 50% of the original amount of pleural fluid on chest roentgenogram, persistent fever (≥ 38.0°C), or elevated peripheral white blood cell count of ≥ 11,000/mm³. These participants were referred to thoracic surgery for further treatment.

Outcomes

Time of outcome measurements: not reported

Primary outcome(s):

  • Length of hospital stay

    • 8.7 ± 0.9 days (VATS) versus 12.8 ± 1.1 days (thoracostomy group); P = 0.009

  • Days in ICU

    • 1.8 ± 1.1 days (VATS) versus 4.2 ± 1.8 days (thoracostomy group); P = 0.26

  • Duration of chest tube drainage

    • 5.8 ± 1.1 days (VATS) versus 9.8 ± 1.3 days (thoracostomy group); P = 0.03

  • Number of chest tubes

    • 1.7 ± 0.1 (VATS) versus 2.1 ± 0.7 (thoracostomy group); P = 0.009

  • Mortality

    • 1 (VATS) versus 1 (thoracostomy group); P = 0.009

  • Complications

    • 0 (VATS) versus 1 (thoracostomy group); P = 0.009

  • Primary treatment success

    • 10 (91%) (VATS) versus 4 (44%) (thoracostomy group); P = 0.05

  • Primary treatment failure

    • 1 (9%) (VATS) versus 5 (56%) (thoracostomy group); P = 0.05

  • Cost

    • USD 16,642 ± USD 2841 (VATS) versus USD 24,052 ± USD 3466 (thoracostomy group); P = 0.11

Secondary outcome(s): Outcomes not divided into primary and secondary.

Other outcome(s): not reported

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Type of funding: not reported

Conflicts of interest: none reported

Stated aim for study: "To determine the optimal treatment of empyema thoracis (within the fibrinopurulent phase of illness) comparing pleural drainage and fibrinolytic therapy versus video‐assisted thoracoscopic surgery (VATS), with regard to efficacy and duration of hospitalisation."

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Not mentioned

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Blinding not possible.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not mentioned. However, outcomes were objectively measured.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

There were no missing outcome data.

Selective reporting (reporting bias)

Low risk

No protocol published. However, all outcomes in methods were included in results.

Other bias

Unclear risk

Funding source not reported.

cm H₂O: centimetre of water (measurement of pressure)
CT: computed tomography
ICU: intensive care unit
IQR: interquartile range
IU: international unit
Fr: French (catheter‐sizing scale)
LDH: lactate dehydrogenase
LOS: length of stay
N: number
STK: streptokinase
tPA: tissue plasminogen activator
Uro: urokinase
VATS: video‐assisted thoracoscopic surgery
WCC: white cell count

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Angelillo 1996

Compared 2 surgical treatments

Bagheri 2013

Patients that failed to recover after 2 weeks of thoracostomy were randomised to receive either VATS or ongoing medical management.

Bouros 1997

Compared 2 non‐surgical treatments

Bouros 1999

Compared 2 non‐surgical treatments

Chin 1997

Compared 2 non‐surgical treatments

Cho 2000

Compared 2 non‐surgical treatments

Davies 1997

Compared 2 non‐surgical treatments

Diacon 2004

Compared 2 non‐surgical treatments

Hewidy 2014

Compared 2 non‐surgical treatments

Lin 2011

Compared 2 non‐surgical treatments

Maskell 2005

Compared 2 non‐surgical treatments

Mathew 2015

Paper was a commentary of a RCT.

Minchev 2004

Compared 2 surgical treatments

Misthos 2005

Compared 2 non‐surgical treatments

Nandeesh 2013

Trial was not randomised.

Rahman 2009

Compared 2 non‐surgical treatments

Rahman 2011

Compared 2 non‐surgical treatments

Sahn 1998

Compared 2 non‐surgical treatments

Shah 2006

Compared 2 non‐surgical treatments

Singh 2004

Compared 2 non‐surgical treatments

Talib 2003

Compared 2 non‐surgical treatments

Thommi 2012

Compared 2 non‐surgical treatments

Thomson 2002

Compared 2 non‐surgical treatments

RCT: randomised controlled trial
VATS: video‐assisted thoracoscopic surgery

Characteristics of studies awaiting assessment [ordered by study ID]

Ahmed 2016

Methods

RCT

Randomisation ratio: open thoracotomy:fibrinolytics = 43:35

Number of study centres: 1

Participants

N recruited = 78

N randomised =78

N reported outcomes = 78

Mean age = thoracotomy 55.53 years; fibrinolytics 56.42 years

Gender m/f = 67/11

N fibrinolysis = 35

N thoracotomy = 43

Inclusion criteria: not described

Exclusion criteria: not described

Interventions

Treatment before study: none reported

Titration period and treatment: After diagnosis, participants were randomly allocated to receive either open thoracotomy or chest tube with fibrinolysis.

Open thoracotomy: Postero‐lateral thoracotomy with complete decortication of parietal and visceral pleura. 2 large‐bore chest tubes (32Fr) were left in place following the procedure.

Fibrinolysis: 14Fr chest tube inserted using Seldinger technique. 250,000 units of streptokinase in 100 mL normal saline was injected and left in place for 4 hours prior to draining. This was repeated every 24 hours for a maximum of 14 days. If drainage continued after 14 days, open drainage was performed.

Common: For both procedures, chest tubes were removed when the drainage volume < 50 mL per day.

Outcomes

Duration of treatment, mean (SD) days: thoracotomy 13.95 (1.02) versus fibrinolysis 12.91 (1.01); P = 0.66

Treatment success, number of participants (%): thoracotomy 42 (97.7) versus fibrinolysis 30 (85.7); P = 0.04

Duration of hospitalisation, mean (SD) days: thoracotomy 12.09 (2.18) versus fibrinolysis 17.6 (1.95); P < 0.0001

Survival, number of participants (%): thoracotomy 42 (97.7) versus fibrinolysis 33 (94.3); P = 0.43

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "To confirm that either Fibrinolytic therapy or open decortication which of the two is an effective First line treatment of pleural empyema."

Funding: no funding

Conflicts of interest: no conflicts of interest

Hasimoto 2015

Methods

RCT

Randomisation ratio: VATS:thoracostomy = 26:28

Number of study centres: not stated

Participants

N recruited = 54

N randomised =54

N reported outcomes = 54

Mean age = not stated

Gender m/f = 31/23

N thoracostomy = 28

N VATS = 26

Inclusion criteria: not described

Exclusion criteria: not described

Interventions

Treatment before study: none reported

Titration period and treatment: After diagnosis, participants were randomly allocated to receive either VATS or thoracostomy.

VATS: No further details provided.

Thoracostomy: No further details provided.

Outcomes

Duration of chest tube drainage (days): VATS 4.46 ± 1.79; thoracostomy 10.36 ± 5.16; P < 0.001

Notes

Language of publication: English

Publication status: peer‐reviewed journal

Stated aim for study: "To analyse cases of parapneumonic pleural empyema in children undergoing chest tube drainage alone or early video‐thoracoscopy in our hospital in order to determine the factors associated with a favourable treatment outcome."

Funding: not stated

Conflicts of interest: no significant relationships

NCT00234208

Methods

Allocation: randomised

Endpoint classification: efficacy study

Intervention model: parallel assignment

Masking: open label

Primary purpose: treatment

Participants

Ages eligible for study: 18 years and older

Inclusion criteria:

  • Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection

  • Frank pleural empyema (pus)

Exclusion criteria:

  • Fibrothorax

  • Tuberculous empyema

  • Medical thoracoscopy cannot be performed within 24 hours

  • Pregnancy

  • Inability to give informed consent

Conducted RCT in 100 patients with complicated parapneumonic effusions with septa or empyema with frank pus

Interventions

Participants will be randomised to receive either simple chest tube drainage or early medical thoracoscopy. The latter will be performed in local anaesthesia and analgosedation according to the standards set by the European Study on Medical Video‐Assisted Thoracoscopy (ESMEVAT) group. Fibrinolysis will be used routinely. A nested study on the intrapleural pharmacokinetics of linezolid as antibiotic agent will be performed in 20 participants.

Follow‐up will be structured on day 1, day 7, before discharge, and after 3 months including chest radiographs and clinical and laboratory evaluations.

Outcomes

Primary outcome measures:

  • Medical cure without secondary intervention [Designated as safety issue: No]

  • Death [Designated as safety issue: Yes]

Secondary outcome measures:

  • Duration of hospital stay [Designated as safety issue: Yes]

  • Radiological outcome [Designated as safety issue: No]

  • Duration of drainage [Designated as safety issue: No]

  • Total amount of drainage fluid [Designated as safety issue: No]

  • Estimated cost [Designated as safety issue: No]

  • Adverse events [Designated as safety issue: Yes]

  • Pleural pharmacokinetics of linezolid [Designated as safety issue: No]

Notes

Responsible party: University Hospital Basel, Switzerland

Zhang 2011

Methods

Patients with empyema who failed to recover with antibiotics and closed‐tube drainage were divided into 2 groups. Group A underwent VATS. Group B were treated with continued drainage and the addition of fibrinolytic therapy.

No further details are available.

Participants

68 patients

Group A = 32 patients

Group B = 36 patients

Patient demographics not available.

Interventions

Group A underwent VATS debridement and decortication.

Group B were treated with continued thoracostomy drainage and the addition of fibrinolytic therapy.

No further details are available.

Outcomes

Length of hospital stay

Chest tube drainage time

Fever duration

Conversion to thoracotomy

Complications

Notes

Study start date: October 2005

Completed: January 2007

RCT: randomised controlled trial
SD: standard deviation
VATS: video‐assisted thoracoscopic surgery

Data and analyses

Open in table viewer
Comparison 1. Open thoracotomy versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

Analysis 1.1

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.

2 Length of hospital stay (days) Show forest plot

1

30

Mean Difference (IV, Random, 95% CI)

‐5.9 [‐7.29, ‐4.51]

Analysis 1.2

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

3 Procedural complications Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.10 [0.02, 0.63]

Analysis 1.3

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.

Open in table viewer
Comparison 2. VATS versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

7

361

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

Analysis 2.1

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.

1.1 Children

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

2 Length of hospital stay (days) Show forest plot

5

231

Mean Difference (IV, Random, 95% CI)

‐2.52 [‐4.26, ‐0.77]

Analysis 2.2

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

2.1 Children

4

211

Mean Difference (IV, Random, 95% CI)

‐1.99 [‐4.36, 0.39]

2.2 Adults

1

20

Mean Difference (IV, Random, 95% CI)

‐4.10 [‐4.99, ‐3.21]

3 Procedural complications Show forest plot

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.08, 2.75]

Analysis 2.3

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.

3.1 Children

3

181

Odds Ratio (M‐H, Random, 95% CI)

0.94 [0.06, 15.48]

3.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.28 [0.03, 2.88]

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).
Figuras y tablas -
Analysis 1.2

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.
Figuras y tablas -
Analysis 1.3

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).
Figuras y tablas -
Analysis 2.2

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.
Figuras y tablas -
Analysis 2.3

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.

Summary of findings for the main comparison. Open thoracotomy compared to thoracostomy drainage for pleural empyema

Open thoracotomy compared to thoracostomy drainage for pleural empyema

Patient or population: children with pleural empyema
Intervention: open thoracotomy
Comparison: thoracostomy drainage

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Thoracostomy drainage

Open thoracotomy

Mortality

Follow‐up: up to 3 months after discharge

Risk in study population

Not estimable

30
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

No deaths occurred in either group.

Length of hospital stay (days)

Follow‐up: up to 3 months after discharge

The mean length of hospital stay in the control group was 15.4 days.

The mean length of hospital stay in the intervention group was 5.9 days fewer (7.29 fewer to 4.51 fewer).

30
(1 RCT)

⊕⊕⊕⊝
MODERATE1

Procedural complications

Follow‐up: up to 3 months after discharge

Risk in study population

OR 0.10
(0.02 to 0.63)

30
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

600 per 1000

130 per 1000
(29 to 486)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded one level due to small sample size and only one study.

Figuras y tablas -
Summary of findings for the main comparison. Open thoracotomy compared to thoracostomy drainage for pleural empyema
Summary of findings 2. VATS compared to thoracostomy drainage for pleural empyema

VATS compared to thoracostomy drainage for pleural empyema

Patient or population: children and adults with pleural empyema
Intervention: VATS
Comparison: thoracostomy drainage

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Thoracostomy drainage

VATS

Mortality

Risk in study population

OR 0.80
(0.04 to 14.89)

361
(7 RCTs)

⊕⊕⊝⊝
LOW1

Data only for adults

6 per 1000

5 per 1000
(0 to 78)

Mortality: children

Risk in study population

Not estimable

271
(5 RCTs)

⊕⊕⊕⊝
MODERATE 2

No deaths occurred in either group.

Not pooled

Not pooled

Mortality: adults

Follow‐up: not reported

Risk in study population

OR 0.80
(0.04 to 14.89)

90
(2 RCTs)

⊕⊕⊕⊝
MODERATE 3

No deaths occurred in Bilgin 2006. Data based on Wait 1997

23 per 1000

18 per 1000
(1 to 257)

Length of hospital stay (days)

Follow‐up: 1 year in Cobanoglu 2011 and 3 months in Marhuenda 2014

Control group

The mean length of hospital stay in the intervention group was 2.52 days fewer (4.26 fewer to 0.77 fewer).

231
(5 RCTs)

⊕⊕⊕⊝
MODERATE4

Note: Follow‐up period not reported in Kurt 2006; Peter 2009; Wait 1997.

Procedural complications

Follow‐up: 6 months in Bilgin 2006 and not reported in Wait 1997

Risk in study population

OR 0.46
(0.08 to 2.75)

271
(5 RCTs)

⊕⊕⊕⊝
MODERATE 5

23 per 1000

11 per 1000
(2 to 60)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial; VATS: video‐assisted thoracoscopic surgery

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded two levels due to wide confidence intervals (data from only one study) and indirectness (data only available for adults).
2Downgraded one level as data not available due to small sample size and no events occurring in the studies.
3Downgraded one level due to small sample size (imprecision) as data available from only one study.
4Downgraded one level due to heterogeneity.
5Downgraded one level due to wide confidence intervals.

Figuras y tablas -
Summary of findings 2. VATS compared to thoracostomy drainage for pleural empyema
Table 1. Total cost of treatment

Trial

Total treatment cost (USD):
thoracostomy arm

Total treatment cost (USD):
VATS arm

P value

Cobanoglu 2011

Mean 386.672 ± 72.06

Mean 957.487 ± 137.238

< 0.001

Kurt 2006

Median (IQR) 21,947 (17,895 to 37,458)

Median (IQR) 19,714 (17,325 to 23,000)

0.315

Sonnappa 2006

Mean 9127

Mean 11,379

< 0.001

Peter 2009

Mean 7600 ± 5400

Mean 11,700 ± 2900

0.02

Wait 1997

Mean 24,052 ± 3466

Mean 16,642 ± 2841

0.11

IQR: interquartile range

Figuras y tablas -
Table 1. Total cost of treatment
Table 2. Duration of chest tube drainage

Trial

Duration of chest tube
drainage: thoracostomy arm (days)

Duration of chest tube drainage:
surgical arm (days)

P value

Cobanoglu 2011

Mean 9.48 ± 2.50

Mean 6.56 ± 1.55

< 0.001

Karaman 2004

Mean 13.8 ± 2.3

Mean 7.5 ± 1.1

< 0.05

Kurt 2006

Mean 9.63 ± 5.45

Mean 2.80 ± 0.63

< 0.001

Marhuenda 2014

Median (IQR) 5 (4 to 6)

Median (IQR) 4 (3 to 5)

< 0.001

Wait 1997

Mean 9.8 ± 1.3

Mean 5.8 ± 1.1

0.03

IQR: interquartile range

Figuras y tablas -
Table 2. Duration of chest tube drainage
Table 3. Postintervention fever duration

Trial

Postintervention fever duration:
thoracostomy arm (days)

Postintervention fever
duration: surgical arm (days)

P value

Cobanoglu 2011

Mean 3.9 ± 2.1

Mean 3.4 ± 2.4

0.782

Kurt 2006

Mean 6.25 ± 4.10

Mean 3.60 ± 2.95

0.146

Marhuenda 2014

Median (IQR) 6 (3 to 7)

Median (IQR) 4 (2 to 7)

0.62

Sonnappa 2006

Median (range) 2.5 (0 to 25)

Median (range) 2.5 (0 to 10)

0.635

Peter 2009

Mean 3.8 ± 2.9

Mean 3.1 ± 2.7

0.46

IQR: interquartile range

Figuras y tablas -
Table 3. Postintervention fever duration
Comparison 1. Open thoracotomy versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 Length of hospital stay (days) Show forest plot

1

30

Mean Difference (IV, Random, 95% CI)

‐5.9 [‐7.29, ‐4.51]

3 Procedural complications Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.10 [0.02, 0.63]

Figuras y tablas -
Comparison 1. Open thoracotomy versus thoracostomy drainage
Comparison 2. VATS versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

7

361

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

1.1 Children

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

2 Length of hospital stay (days) Show forest plot

5

231

Mean Difference (IV, Random, 95% CI)

‐2.52 [‐4.26, ‐0.77]

2.1 Children

4

211

Mean Difference (IV, Random, 95% CI)

‐1.99 [‐4.36, 0.39]

2.2 Adults

1

20

Mean Difference (IV, Random, 95% CI)

‐4.10 [‐4.99, ‐3.21]

3 Procedural complications Show forest plot

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.08, 2.75]

3.1 Children

3

181

Odds Ratio (M‐H, Random, 95% CI)

0.94 [0.06, 15.48]

3.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.28 [0.03, 2.88]

Figuras y tablas -
Comparison 2. VATS versus thoracostomy drainage