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Prophylaxie antimicrobienne systémique pour la gastrostomie percutanée endoscopique

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Referencias

References to studies included in this review

Ahmad 2003 {published data only}

Ahmad I, Mouncher A, Abdoolah A, Stenson R, Wright J, Daniels A, et al. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy a prospective, randomised, double‐blind trial. Alimentary Pharmacology Therapy 2003;18(2):209‐15.

Akkersdijk 1995 {published data only}

Akkersdijk WL, Van Bergeijk JD, Van Egmond T, Mulder CJ, Van Berge Henegouwen GP, Van der Werken C, et al. Percutaneous endoscopic gastrostomy (PEG): comparison of push and pull methods and evaluation of antibiotic prophylaxis. Endoscopy 1995;27(4):313‐6.

Blomberg 2010 {published data only}

Blomberg J, Lagergren P, Martin L, Mattsson F, Lagergren J. Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial. BMJ 2010;341:c3115 doi: 10.1136/bmj.c3115. [DOI: 10.1136/bmj.c3115]

Dormann 2000 {published data only}

Dormann A J, Wiggenhaus B, Huchzermeyer H. Antibiotic prophylaxis in percutane endoscopical gastrostomy (PEG). Endoskopie Heute 1999;12(1):16.
Dormann A, Wiggenhaus B, Risius H, Kleimann F, Kloppenborg A, Grunewald T, et al. A single dose of ceftriaxone administered 30 minutes before percutaneous endoscopic gastrostomy significantly reduces local and systemic infective complications. American Journal of Gastroenterology 1999;94(11):3220‐4.
Dormann A, Wiggenhaus B, Risius H, Kleimann F, Kloppenborg A, Padel Y, et al. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy. Preliminary results of a prospective randomized multicenter study. Chemotherapie Journal 2000;9(3):131‐5.
Dormann A, Wigginhaus B, Risius H, Kleimann F, Kloppenborg A, Rosemann J, et al. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG) ‐ results from a prospective randomized multicenter trial. Zeitschrift fur Gastroenterologie 2000;38(3):229‐34.
Dormann AJ, Huchzermeyer H. Efficienca and economy of antibiotic prophylaxis in percutane endoscopical gastrostomy (PEG). Der Neidergelassene Chirurgerie 2000;4(5):40‐4.

Gossner 1999 {published data only}

Gossner L, Keymling J, Hahn E, Ell C. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG) a prospective randomized clinical trial. Endoscopy 1999;31(2):119‐24.
Gossner L, Keymling J, Hahn EG, et al. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): A prospective randomized clinical trial. Gastroenterology 1997;112:A877.
Gossner L, Keymling J, Yazji HJ, Konig EG, Hahn C. A prospective randomised study comparing the effectiveness of antibiotic prophylaxis in PEG insertion. Endoskopie Heute 1995;1:95.

Jain 1987 {published data only}

Jain NK, Larson DE, Schroder KW, Burton DD, Cannon KP, Thompson RL, et al. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy. Annals of Internal Medicine 1987;107(6):824‐8.

Jonas 1985 {published data only}

Jonas SK, Neimark S, Panwalker AP. Effect of antibiotic prophylaxis in percutaneous endoscopic gastrostomy. American Journal of Gastroenterology 1985;80(6):438‐41.

Panigrahi 2002 {published data only}

Panigrahi H, Shreeve D, Tan W, Prudham R, Kaufman R. Role of antibiotic prophylaxis for wound infection in percutaneous endoscopic gastrostomy (PEG): result of a prospective double‐blind randomized trial. Journal of Hospital infection 2002;50(4):312‐5.

Preclik 1999 {published data only}

Grune S, Kern W, Preclik G, Hub J, Lebherz J, Leser H, et al. Using a single dose of amoxycillin/clavulanic acid (am/c) reduces the risk of infections in percutaneous endoscopic gastrostomy (PEG); results of a prospective randomised double blind trial. Digestion 1998;59(Supplement 3):44.
Preclick G, Grune S, Leser H, Lebherz J, Heldwein W, Madchka K, et al. Prospective, randomised, double blind trial of prophylaxis with single dose of co‐amoxiclav before endoscopic gastrostomy. BMJ 1999;319(7214):881‐4.

Radhakrishnan 2006 {published data only}

Radhakrishnan NV, Shenoy AH, Cartmill I, Sharma RK, George R, Foster DN, et al. Addition of local antiseptic spray to parental antibiotic regimen reduces the incidence of stomal infection following percutaneous endoscopic gastrostomy: a randomized controlled trial. European Journal of Gastroenterology and Hepatology 2006;18(12):1279‐83.

Saadeddin 2005 {published data only}

Saadeddin A, Freshwater DA, Fisher NC, Jones JM. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy for non‐malignant conditions: a double‐blind randomized controlled trial. Alimentary Pharmacology Therapy 2005;22(6):565‐70.

Shastri 2008 {published data only}

Shastri YM, Hoepffner N, Tessmer A, Ackermann H, Schroeder O, Stein J. New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double‐blind placebo‐controlled study. Gastrointestinal Endoscopy 2008;67(4):620‐8.

Sturgis 1996 {published data only}

Sturgis TM, Yancy W, Cole JC, Proctor DD, Minhas BS, Marcuard SP. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy. American Journal of Gastroenterology 1996;91(11):2301‐4.

References to studies excluded from this review

Adachi 2002 {published data only}

Adachi S, Oura G, Sawai M, Ikenaka Y. The prophylaxis of wound infection in pull‐percutaneous endoscopic gastrostomy. Nippon Shkakibyo Gakkai Zasshi 2002;99(1):21‐6.

Arrowsmith 1997 {published data only}

Arrowsmith H, Tracey M, Chesner IM. Is a single dose of prophylactic antibiotics effective in preventing stoma infections following PEG insertion. Gut 1997;40(3s):64A.

Beales 2003 {published data only}

Beales I, McGovern J. Antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy. Alimentary Pharmacology and Therapeutics 2003;18(9):947.

Chowdhury 1996 {published data only}

Chowdhury M, Batey R. Complications and outcome of percutaneous endoscopic gastrostomy in different patient groups. Journal of Gastroenterology and Hepatology 1996;11(9):835‐9.

Dormann 2004 {published data only}

Dormann AJ, Deppe H, Kahl S, Wejda B, Malfertheiner P. Skin‐level gastrostomy ‐ Long‐term results from a prospective trial in gastric and jejunal application. Zeitschrift fur Gastroenterologie 2004;42(11):1283‐8.

Gawenda 1997 {published data only}

Gawenda M, Wolfgarten B, Schaefer H, Walter M. Effect of antibiotic prophylaxis in percutaneous endoscopic gastrostomy. British Journal of Surgery 1997;84(Supplement 2):59.

Gopal 2004 {published data only}

Gopal Rao G, Osman M, Johnson L, Ramsey D, Jones S, Fidler H. Prevention of percutaneous endoscopic gastrostomy site infections caused by methicillin‐resistant Staphylococcus aureus. Journal of Hospital Infection 2004;58(1):81‐3.

Horiuchi 2006 {published data only}

Horiuchi A, Nakayama Y, Kajiyama M, Fujii H, Tanaka N. Nasopharyngeal decolonization of methicillin‐resistant Staphylococcus aureus can reduce PEG peristomal wound infection. Amercian Journal of Gastroenterology 2006;101:274‐7.

Hull 2001 {published data only}

Hull M, Beane A, Bowen J, Settle C. Methicillin‐resistant Staphylococcus aureus infection of percutaneous endoscopic gastrostomy sites. Alimentary Pharmacology and Therapeutics 2001;15(12):1883‐8.

Jafri 2007 {published data only}

Jafri NS, Mahid SS, Minor KS, Idstein SR, Hornung CA, Galandiuk S. Meta‐analysis: antibiotic prophylaxis to prevent peristomal infection following percutaneous endoscopic gastrostomy. Alimentary Pharmacology and Therapeutics 2007;25(6):647‐56.

Kanie 2000 {published data only}

Kanie J, Kono K, Osawa M, Yamamoto T, Akatsu H, Shimokata H, et al. Complications of percutaneous endoscopic gastrostomy in the elderly: local skin infection and respiratory infection. Nippon Ronen Igakkai Zasshi 2000;37(2):143‐8.

Lee 2002 {published data only}

Lee L, Kim J, Kim Y, Yang J, Son H, Peck K, et al. Increased risk of peristomal wound infection after percutaneous endoscopic gastrostomy in patients with diabetes mellitus. Digestive and Liver Disease 2002;34(12):857‐61.

Loser 2000 {published data only}

Loser C, Keymling M. Antibiotic prophylaxis before percutaneous endoscopic gastrostomy (PEG catheter). Zietschrift fur Gastroenterologie 2000;38(3):271‐3.

Maetani 2003 {published data only}

Maetani I, Tada T, Ukita T, Inoue H, Sakai Y. PEG with introducer or pull method: a prospective randomized comparison. Gastrointestinal Endoscopy 2003;57(7):837‐41.

Maetani 2005 {published data only}

Maetani I, Masatoshi Y, Mashiro S, Masaki I, Tomoko T, Takeo U, et al. Efficacy of an overtube for reducing the risk of peristomal infection after PEG placement: a prospective, randomized comparison study. Gastrointestinal Endoscopy 2005;61(4):522‐7.

Rey 1998 {published data only}

Rey J, Budzynska A, Axon A, Kruse A, Nowak A. Antibiotic prophylaxis for gastrointestinal endoscopy. European Society of Gastrointestinal Endoscopy1988:1‐12.

Sharma 2000 {published data only}

Sharma VK, Howden CW. Meta‐analysis of randomized, controlled trials of antibiotic prophylaxis before percutaneous endoscopic gastrostomy. American Journal of Gastroenterology 2000;95(11):3133‐6.

BMA and RPS 2004

British Medical Association and Royal Pharmacology Society of Great Britain. British National Formulary. London: British Medical Association, 2004.

BSG 2001

British Society for Gastroenterology. Antibiotic prophylaxis in gastrointestinal endoscopy: Guidelines in gastroenterology. Report. British Society of Gastroenterology, 2001.

Calton 1992

Calton W, Martindale R, Gooden S. Complications of percutaneous endoscopic gastrostomy. Military Medicine 1992;157(7):358‐60.

Deeks 1996

Deeks J, Glanville J, Sheldon T. Undertaking systematic reviews on effectiveness. CRD Report 41996.

Gauderer 1980

Gauderer M, Ponsky J. Gastrostomy without laparotomy: a percutaneous endoscopic technique. Journal of Paediatric Surgery 1980;15(6):872‐5.

Geeganage 2012

Geeganage C, Beavan J, Ellender S, Bath PMW. Interventions for dysphagia and nutritional support in acute and subacute stroke. Cochrane Database of Systematic Reviews 2012, Issue 10. [DOI: 10.1002/14651858.CD000323]

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327(7414):557‐60.

Higgins 2011

Higgins JPT, Altman DG, on behalf of the Cochrane Statistical Methods Group and the Cochrane Bias Methods Group (Editors). Chapter 8: Assessing risk of bias in included studies.. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Kulling 2000

Kulling D, Sonnenberg A, Fried M, Bauerfeind P. Cost analysis of antibiotic prophylaxis for PEG. Gastrointestinal Endoscopy 2000;51(2):152‐6.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J, on behalf of the Cochrane Information Retrieval Methods Group. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Locke 2000

Locke GR, Pemberton JH, Phillips SF. AGA technical review on constipation. Gastroenterology 2000;119(6):1766‐78.

Mangram 1999

Mangram A, Horan T, Pearson M, Silver L, Jarvis W. Guideline for prevention of surgical site infection: CDC US Department of Health and Human Services. Infection Control and Hospital Epidemiology 1999;20(4):247‐78.

Nicholson 2000

Nicholson FB, Korman MG, Richardson MA. Percutaneous endoscopic gastrostomy: A review of indications, complications and outcome. Journal of Gastroenterology and Hepatology 2000;15(1):21‐5.

Ogundipe 2004

Ogundipe OA, Kar‐Purkayastha S. An audit of antibiotics usage and their effect on MRSA infection or colonisation following percutaneous endoscopic gastrostomy in a district general hospital. International Journal of Clinical Practice 2004;58(6):632‐4.

Perry 2002

Perry JJ, Staley JT, Lorry S. Microbial Life. 1st Edition. Massachusetts: Sineaur, 2002.

SIGN 2008

Scottish Intercollegiate Guidelines Network (SIGN). Search filters. http://www.sign.ac.uk/methodology/filters.html#random Accessed 6/02/2008 (accessed 6 February 2008).

Skelly 2002

Skelly RH, Kupfer RM, Metcalfe ME, Allison SP, Holt M, Hull MA, et al. Percutaneous endoscopic gastrostomy (PEG): change in practice since 1988. Clinical Nutrition 2002;21(5):389‐94.

Tham 1997

Tham T, Taitelbaum G, Carr‐Locke D. Percutaneous endoscopic gastrostomies: are they being done for the right reasons?. Quarterly Journal of Medicine 1997;90(8):495‐6.

Wilson 1995

Wilson AP. Surveillance of wound infections. Journal of Hospital Infection 1995;29(2):81‐6.

References to other published versions of this review

Lipp 2009

Lipp A, Lusardi G. A systematic review of prophylactic antimicrobials in PEG placement. Journal of Clinical Nursing 2009;18(7):938‐48.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ahmad 2003

Methods

Randomised controlled trial.

Participants

Male and female patients.
Over 18 years.
PEG tube inserted for CVA (n= 38) CNS disorders (n= 20), oropharyngeal cancer (n= 18) and miscellaneous (n= 26) (Taken from Table 1 ‐ 102 patients evaluable on a per protocol analysis).
Excluded if no consent or suspected/confirmed allergy to antibiotic used.
Total number of patients randomised; n = 141.

Interventions

'Pull' technique
Group 1: cefuroxime 750 mg IV 30 min prior to PEG (n = 50);
Group 2: saline placebo IV 30 min prior to PEG (n = 51);
Group 3: receiving antibiotics before and during the study (n = 40).

Outcomes

Peristomal infection.
Complications.

Notes

Group 3 excluded from analysis as not randomised.Used Jain et al criteria for wound assessment.
Country of origin: Wales.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Predetermined computer‐generated randomisation scheme.

Allocation concealment (selection bias)

Unclear risk

Review authors unable to contact study authors for clarification.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Patients received intravenous antibiotics or saline.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Procedure by doctor or nurse not involved in the study.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Blinded to treatment group.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Unclear risk

8 (5.6%) of 141 patients excluded because of incomplete data.

Comment: A 5.6% drop out rate makes the study at unclear risk of attrition bias. However the study reports 133 patients "were analysable on an intention to treat analysis".

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Balanced for gender, age, reason for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

In all groups outcomes were assessed immediately after procedure plus three, five and seven days.

Akkersdijk 1995

Methods

Randomised controlled trial.

Participants

Consecutive male and female patients.

PEG tube inserted for oropharyngeal cancer (n= 56), neurological (n= 32) and other (n= 12).
Inclusion and exclusion criteria not stated.
Total number of patients randomised; n = 100.

Interventions

'Pull' and 'push' techniques.
Group 1: Pull, augmentin 1.2 g IV 3 doses given, 1st dose 30 min prior to procedure two doses administered over 24 hours (n = 37);
Group 2: pull, no placebo, no antibiotic (n = 34);
Group 3: push, no placebo, no antibiotic (n = 29).

Outcomes

Peristomal infection.
Major and minor complications.
Comparison between push and pull technique.

Notes

Criteria for wound assessment: minor infection present if redness with or without purulent discharge, major infection judged by physician as those requiring antibiotics.
Country of origin: Netherlands.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated; no placebo given.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

PEG placement failed in four patients (4%).

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, reason for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes assessed in all groups twice weekly for one month.

Blomberg 2010

Methods

Randomised controlled trial

Participants

Male and female patients.

PEG tube inserted for ear, nose or throat cancer (127), neurological disease (42), oesophageal cancer (n= 30), stroke (n= 11), dementia (n= 1), gastric cancer (n= 1), and other (n= 22).

Included if able to consent to participation in the study after receiving oral and written information
or did not meet exclusion criteria and no contraindications for PEG.

Excluded if ongoing antibiotic treatment, illness too severe to allow the patient to participate, allergy to any of the antibiotic alternatives.

Total number of patients randomised; n = 234

Interventions

Pull technique.
Group 1: Co‐trimoxazole (800mg sulfamethoxazole &160mg trimethoprim) in 20ml deposited in the PEG immediately after insertion (n=116).
Group 2: Cefuroxime 1.5g IV given 1 hour before PEG insertion (n= 118).

Outcomes

Primary outcome ‐ wound infection

Clinically evident peristomal infection at follow up appointment infection within 7‐ 14 days after insertion of the PEG catheter.
Secondary outcomes ‐ Positive bacterial culture or blood biochemistry.

Notes

Criteria for wound assessment: a clinically identifiable wound infection, as judged by a red zone around the catheter or occurrence of pus, subcutaneous swelling, and pain on palpation in the area around the catheter.
Secondary outcomes objective signs of infection, including a positive bacterial culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Country of origin: Sweden.
Power calculation performed for non‐inferiority.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The randomisation process was conducted by personnel at a hospital department not engaged in the care of the included patients"
"Personnel were contacted by telephone and on request opened a closed envelope, taken from a pre‐prepared block (50 envelopes in each block) of equally distributed and mixed envelopes, containing a randomisation sheet with information on the drug to be used"

Allocation concealment (selection bias)

Low risk

"The randomisation process was conducted by personnel at a hospital department not engaged in the care of the included patients"
"Personnel were contacted by telephone and on request opened a closed envelope, taken from a pre‐prepared block (50 envelopes in each block) of equally distributed and mixed envelopes, containing a randomisation sheet with information on the drug to be used"

Blinding (performance bias and detection bias)
Blinding patient

Low risk

"the blinding of the patients was accomplished by using intravenous fluid and manipulating the newly inserted PEG catheter in all patients. This sham manoeuvre was facilitated by the use of sedation"

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

"The nurses who evaluated the patients at follow‐up visit were not involved in insertion of the PEG catheter, including the administration of antibiotics"

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

High risk

Out of 34 dropouts (14.5%) or withdrawals, a total of twelve participants in each group did not undergo PEG placement for anatomical reasons. Other attrition included five deaths, one patient pulled out PEG, three lost to follow‐up and one received co‐trimoxazole after being randomised to cefuroxime.

Comment: 15% drop out rate makes the study at high risk of attrition bias, but ITT analysis undertaken.

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age,smoking, diabetes, indications for PEG.Slight gender imbalance 42 females in group 1 versus 31 females in group 2.

Timing of outcome assessment similar in all groups?

Low risk

7‐14 days for both groups.

Dormann 2000

Methods

Randomised controlled trial.

Participants

Male and female patients aged over 18 years requiring enteral feeding via PEG tube > six weeks.

PEG tube inserted for neurological disease (n= 145), tumour (n= 63) and other (n= 8). (Taken from Table 1 ‐ 216 patients evaluable as 21 dropouts).
Excluded if signs of infection, peritonitis ascites, peritoneal malignancy, prior gastric/bowel disease, granulocytopenia, previous radio/chemotherapy, antibiotic treatment within previous 72 h, clotting/platelet disorders, sensitivity to ceftriaxone.
Total number of patients randomised; n = 237.

Interventions

'Pull' technique:
Group 1: ceftriaxone 1 g IV 30 min prior to PEG (n = 106);
Group 2: no placebo, no antibiotic (n = 110).

Numbers originally randomised into groups not given in trial report.

Outcomes

Peristomal infection.
Mortality.
Cost of antibiotic therapy.
Post‐intervention antibiotic therapy.

Notes

Used modified Jain et al criteria for wound assessment.
Data from four previous studies incorporated into this study.
Data from previous study (1999a), sponsored by Hoffman La Roche, incorporated into this study.
Conducted in 12 secondary and tertiary medical centres.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomised in blocks of four using Rancode 3.1.

Allocation concealment (selection bias)

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

'Study monitors' involved but specific role not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

21 drop outs (8.9%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups balanced for gender, age, reasons for PEG tube, BMI,indications for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed at one, two, four and ten days (mean 8.7).

Gossner 1999

Methods

Randomised controlled trial.

Participants

Male and female patients with proportionately more males (n = 243) than females (n = 93).

PEG tube inserted for malignant disease (n= 210), neurological disorders (n= 97). (Taken from Table 1 ‐ 307 patients evaluable as 40 dropouts).

Included if had functional resorption and digestive capacity with temporary, or permanent, dysphagia.
Excluded if severe clotting or wound healing disorder, pronounced immune deficiency, paralytic ileus, Billroth II procedure, peritonitis, ascites, sensitive to antibiotics used.
Total number of patients randomised; n = 347.

Interventions

Modified 'pull' technique.
Group 1: cefotaxime 2 g by infusion 30 min prior to PEG (n = 101);
Group 2: piperacillin 2 g + 0.5 g tazobactam by infusion (n = 100);
Group 3: no placebo, no antibiotic (n = 106).
Infusion given over 20 min.

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Peritonitis.
Mortality.

Notes

Used Jain et al and Shapiro et al criteria for wound assessment.
Included data from a previous study.
Country of origin: Germany.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated.

Allocation concealment (selection bias)

High risk

Randomly assigned to group after consent taken, and at least one day before procedure.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

40 drop outs (11.5%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, gender, weight, Karnofksy index, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for seven days. Those discharged were assessed over the telephone or via the outpatient department, but the group was not specified.

Jain 1987

Methods

Randomised controlled trial.

Participants

Male and female patients (distribution not stated) who had given consent.

PEG tube inserted for CVA (n= 53), oropharyngeal cancer (n= 27), CNS trauma (n= 8), CNS infection (n= 3), CNS degenerative disease (n= 10) and miscellaneous (n= 6).
Excluded if: allergic to cefazolin, refused signed consent, technical reasons for PEG placement.
Total number of patients randomised; n = 107.

Interventions

Technique not stated, but presumed to be 'pull' as the authors state 'the feeding tube traverses the mouth and pharynx'.
Group 1: receiving antibiotics before and during the study and were randomly assigned to:
Group 1 a: cefazolin 1 g IV 30 min prior to PEG (n = 25);
Group 1 b: saline placebo IV 30 min prior to PEG (n = 27);

Group 2 not receiving antibiotics were randomly assigned to:
Group 2 a: cefazolin 1 g IV 30 min prior to PEG (n = 27);
Group 2 b: saline placebo IV 30 min prior to PEG (n = 28).

Outcomes

Peristomal infection.

Notes

Criteria for wound assessment scoring devised by Jain et al which used indicators previously used by Shapiro et al (1982).
Group 1 excluded from grouped analysis.
Country of origin: USA.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation schedule generated by Hewlitt‐Packard HP‐67 pocket calculator.

Allocation concealment (selection bias)

Low risk

One author (KPC) was responsible for (and the only one aware of) assignment and did not evaluate the wounds.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Outcomes assessed by team members blind to placebo allocation.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Unclear risk

All groups were balanced for gender, underlying conditions, reasons for PEG. In group 1 the mean age was slightly but significantly less than that of patients who did not receive prophylaxis.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for seven days.

Jonas 1985

Methods

Randomised controlled trial.

Participants

All male patients with dysphagia, consent, and functionally‐intact gastrointestinal tract.

PEG tube inserted for underlying malignancy (n= 18) and neurological (n= 15). (Taken from Table 4 ‐ 33 patients evaluable as 4 dropouts).
Excluded if had gastric ulcer/cancer, active infection requiring antibiotics, peritonitis, ascites, extensive abdominal surgery, contraindications to endoscopy, hypersensitivity to cephalosporins, or refused consent.
Total number of patients randomised; n = 37.

Interventions

'Pull' technique:
Group 1: cefoxitin 1 g IV 30 min prior to PEG (2 further doses given at 6 h intervals) (n = 17);
Group 2: saline placebo IV 30 min prior to PEG (n = 16).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Effect of gastric pH.
Microbiology of oropharyngeal flora and tip of tube.
Effect of underlying disease (neurological/malignancy).

Notes

Criteria for wound assessment: red, tender, indurated area at exit site with pain ± systemic signs of leukocytosis and fever.
Country of origin USA.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random sequence generated by pharmacist.

Allocation concealment (selection bias)

Low risk

Allocation concealment as 'foil‐covered vials of identical appearance and equivalent volume' by pharmacy.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated: 'foil‐covered vials of identical appearance and equivalent volume'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated: 'foil‐covered vials of identical appearance and equivalent volume'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Known to pharmacist only.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

Four drop outs (10.8%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for malignancy, neurological disease.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed at more than three days (endpoint not stated).

Panigrahi 2002

Methods

Randomised controlled trial.

Participants

Consenting male and female patients, who had not received antibiotics in the preceding three days.

PEG tube inserted for neurological (n= 49), Cancer (n= 4) and miscellaneous (n= 5). (Taken from Table 1 ‐ 58 patients evaluable as 17 dropouts).
Excluded if allergic to penicillin, immunocompromised, had severe clotting disorder, end‐stage renal failure, or gastrointestinal surgery which precluded site of PEG.
Total number of patients randomised; n = 75.

Interventions

Technique not stated.
Group 1: co‐amoxiclav (dose not stated) IV 15‐30 min prior to PEG (n = 29);
Group 2: saline placebo IV 15‐30 min prior to PEG (n = 29).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.

Notes

Criteria for wound assessment: modified ASEPSIS scoring system used.
Country of origin England.
No power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Provided by the hospital pharmacy'.

Allocation concealment (selection bias)

Low risk

Administered by 'endoscopist 15‐30 min prior to endoscopy with no prior knowledge of the sequence in the randomisation'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

'The infection control team was blinded to the randomisation'.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

High risk

17 in total, seven died, eight drop outs, two lost to follow‐up (22.6%).

Comment: A 15% drop out rate makes the study at high risk of attrition bias.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days, and then day 28.

Preclik 1999

Methods

Randomised controlled trial.

Participants

Consenting male and female patients with dysphagia, 18 years and over.

PEG tube inserted for malignancy (n= 55) and neurological disease (n= 29) (Taken from Table 1 ‐ 84 patients evaluable on a per protocol analysis).
Excluded if had: allergy to penicillin; received antibiotics in past 4 days; neutropenia < 500 cells/microlitre; creatinine < 300 micromols/litre or contraindication to PEG.
Total number of patients randomised; n = 106.

Interventions

Thread 'pull' technique.
Group 1: co‐amoxiclav 2.2 g, by short infusion 30 min prior to PEG (n = 46).
Group 2: saline placebo, by short infusion 30 min prior to PEG (n = 47).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Mortality.
Adverse effects.

Notes

Included data from a previous study.
Used criteria by Jain et al for wound assessment.
Conducted in six hospitals.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Permuted block design with separate sequences of random numbers for each centre to ensure equal numbers.

Allocation concealment (selection bias)

Low risk

Prepared by pharmacy.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Blinding of investigators, study nurses, reviewers and data managers.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Blinding of investigators, study nurses, reviewers and data managers.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Unclear risk

13 drop outs (12.3%). Report stated that ITT analysis was performed on 93 patients who received PEG but 106 patients were randomised and 13 people dropped out and there are no details on how this missing data were handled. The judgement is therefore unclear.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes stated.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, previous method of feeding, underlying conditions, performance status reason for PEG, Karnofsky index.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days and mortality at 30 days.

Radhakrishnan 2006

Methods

Randomised controlled trial.

Participants

Consenting male and female patients who had not received antibiotics in the preceding 2 days.

PEG tube inserted for CVA (n= 57), dementia (n= 10), neurogenic dysphagia (n= 11) and miscellaneous (n= 18).
Excluded if on antibiotic therapy, unable to gain consent, had allergy to cephalosporin or iodine, or required prophylaxis for endocarditis.
Total number of patients randomised; n = 96.

Interventions

'Pull' technique.
Group 1: cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34);
Group 2: povidone‐iodine spray only (n = 28);
Group 3: povidone‐iodine spray and cefuroxime 750 mg IV immediately prior to PEG (2 further doses given at 8 h intervals) (n = 34).

Outcomes

Peristomal infection.
Mortality.
Logistic regression effects of diabetes, steroids, acid suppressants, age and sex.

Notes

Used Jain et al wound assessment.
Some patients received antibiotics during follow‐up period.
Country of origin: England.
Power calculation not performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Closed envelopes opened at random by an endoscopy nurse.

Allocation concealment (selection bias)

Low risk

'Closed envelopes that were shuffled and opened at random by an endoscopy nurse after the patient had given consent for the study'.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Stomal site inspected by the investigator who was blinded to regime.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs, five patient deaths in 1 week, 1 from gastric leakage on day 6 (5.2%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, gender, steroids, diabetes, size of PEG tube, reasons for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed on day three or four and day seven.

Saadeddin 2005

Methods

Randomised controlled trial.

Participants

Male and female patients over 16 years of age.

PEG tube inserted for CVA (n= 61), neurological (n= 35) and miscellaneous (n= 5). (Taken from Table 2 Error in paper as these total 101. The number quoted as 'analysable' for each outcome is 83 for peristomal infection, 97 for systemic infection, and 99 for seven‐day mortality).
Included if PEG was for non‐malignancy.
Excluded if had antibiotics within 48 h preceding PEG insertion.
Total number of patients randomised; n = 110.

Interventions

Pull technique.
Group 1: co‐amoxiclav 2.2 g (n = 43), or cefotaxime 2 g (if allergic to penicillin) (n = 8) at time of PEG tube insertion.
Group 2: placebo (not stated) at time of PEG tube insertion (n = 48).

Numbers originally randomised into groups not given in trial report

Outcomes

Peristomal infection.
Systemic infection.
Seven‐day mortality.

Notes

Used Jain et al criteria for wound assessment.
Country of origin: England.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Done in advance using a random number generator'.

Allocation concealment (selection bias)

Low risk

'Study assignment cards kept with medication packs in pharmacy'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

'Patient blinded'. Syringe covered with opaque sleeve prepared by endoscopy nurse.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Syringe covered with opaque sleeve prepared by endoscopy nurse.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

'Study investigator (outcome assessor) blinded'.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

11 withdrawals (10%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes addressed.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, weight, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days.

Shastri 2008

Methods

Randomised controlled trial.

Participants

Male and female patients 16‐89 years.

PEG tube inserted for cancer (n= 93). (Taken from Figure 1 ‐ 93 patients evaluable as 4 dropouts).
Included if had stenotic malignancy and lesions of the upper gastrointestinal tract.
Excluded if allergic to antibiotics, or had any contraindications to PEG.
Total number of patients randomised; n = 97.

Interventions

Push technique gastropexy PEG.
Group 1: ceftriaxone 2 g IV (n = 49);
Group 2: placebo ('similar looking') IV (n = 48).

Outcomes

Peristomal infection.

Notes

Used Jain et al and Gossner criteria for wound assessment.
Country of origin: Germany.
Power calculation performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Block randomisation and computer‐generated random numbers'.

Allocation concealment (selection bias)

Low risk

'Sequentially numbered, opaque, sealed envelopes'.

Blinding (performance bias and detection bias)
Blinding patient

Unclear risk

Not stated.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Injections prepared by non‐study staff.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Low risk

Wound assessment by members of nutrition support team.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

Four drop outs (4.1%).

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

Both groups were balanced for age, gender, BMI, location of malignancy, reason for PEG.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in both groups were assessed daily for seven days.

Sturgis 1996

Methods

Randomised controlled trial.

Participants

Characteristics of patients unclear.

PEG tube inserted for CVA and head and neck cancer (no numbers provided).
Excluded if unable to place PEG, inadequate access to follow‐up by medical personnel, or refused to sign consent form.
Total number of patients randomised; n = 115.

Interventions

Technique not stated.
Group 1: cefazolin 1 g IV within 30 min of PEG (n = 30);
Group 2: saline placebo IV within 30 min of PEG (n = 31);
Group 3: receiving antibiotics (including cephalosporins, penicillins, quinolones and sulphonamides) before and during the study which were continued for 24 h post PEG (n = 54).

Outcomes

Peristomal infection.
Gastric pH.
Wound cultures.

Notes

Group 3 excluded from analysis, as not randomised.
Used Jain et al criteria for wound assessment.
Country of origin: USA.

Power calculation not performed.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

'Generated random sequence known only to those in the pharmacy'.

Allocation concealment (selection bias)

Low risk

Pharmacy dispensed 'Identical vials with equivalent volume'.

Blinding (performance bias and detection bias)
Blinding patient

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding care provider

Low risk

Stated as 'double blind'.

Blinding (performance bias and detection bias)
Blinding outcome assessor

Unclear risk

Not stated.

Incomplete outcome data (attrition bias)
Drop outs/withdrawals

Low risk

No drop outs.

Selective reporting (reporting bias)

Low risk

Prespecified outcomes reported.

Baseline imbalance? (Was the study free of baseline imbalance?)

Low risk

All groups were balanced for age, reasons for PEG, underlying conditions.

Timing of outcome assessment similar in all groups?

Low risk

Outcomes in all groups were assessed daily for one week.

Abbreviations

> = more than
± = with or without
ITT = intention‐to‐treat analysis
IV = intravenous

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Adachi 2002

Not an RCT.

Arrowsmith 1997

Not an RCT but an audit.

Beales 2003

A critique of two RCTs.

Chowdhury 1996

Not an RCT.

Dormann 2004

Not an RCT but a cohort study that did not investigate the use of antibiotics.

Gawenda 1997

Abstract only: unable to obtain study data via trial authors or full‐text article via British Library.

Gopal 2004

Not an RCT.

Horiuchi 2006

All patients received prophylactic and concomitant antibiotics.

Hull 2001

Not an RCT: did not investigate the use of antibiotics.

Jafri 2007

A systematic review. The patient data included were a duplicate of those in the included studies.

Kanie 2000

Examined PEG feeding not placement.

Lee 2002

Not an RCT.

Loser 2000

Not an RCT.

Maetani 2003

A comparison between push and pull methods of placement. Antibiotics were given to all patients.

Maetani 2005

A comparison of the use of an over tube to reduce infection in PEG tube placement. Antibiotics were given to all patients.

Rey 1998

Not an RCT.

Sharma 2000

A systematic review. The patient data included were a duplicate of those in the included studies.

Data and analyses

Open in table viewer
Comparison 1. Systemic antibiotic (IV) compared with placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

8

586

Odds Ratio (M‐H, Fixed, 95% CI)

0.34 [0.22, 0.53]

Analysis 1.1

Comparison 1 Systemic antibiotic (IV) compared with placebo, Outcome 1 Peristomal infection.

Comparison 1 Systemic antibiotic (IV) compared with placebo, Outcome 1 Peristomal infection.

Open in table viewer
Comparison 2. Systemic antibiotic (IV) compared with no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

3

623

Odds Ratio (M‐H, Fixed, 95% CI)

0.30 [0.17, 0.53]

Analysis 2.1

Comparison 2 Systemic antibiotic (IV) compared with no intervention, Outcome 1 Peristomal infection.

Comparison 2 Systemic antibiotic (IV) compared with no intervention, Outcome 1 Peristomal infection.

Open in table viewer
Comparison 3. Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.36 [0.26, 0.50]

Analysis 3.1

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 1 Peristomal infection.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 1 Peristomal infection.

2 Allocation concealment Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.47 [0.34, 0.65]

Analysis 3.2

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 2 Allocation concealment.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 2 Allocation concealment.

2.1 adequate allocation concealment

8

554

Odds Ratio (M‐H, Fixed, 95% CI)

0.58 [0.38, 0.88]

2.2 unclear/inadequate concealment

4

717

Odds Ratio (M‐H, Fixed, 95% CI)

0.34 [0.21, 0.58]

3 Sponsorship Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.36 [0.26, 0.50]

Analysis 3.3

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 3 Sponsorship.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 3 Sponsorship.

3.1 Trials with no sponsorship

10

962

Odds Ratio (M‐H, Fixed, 95% CI)

0.38 [0.25, 0.56]

3.2 Trials with sponsorship

2

309

Odds Ratio (M‐H, Fixed, 95% CI)

0.32 [0.18, 0.58]

Open in table viewer
Comparison 4. Systemic antibiotic compared with systemic antibiotic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Systemic antibiotic (IV) compared with systemic antibiotic (IV) Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 4.1

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 1 Systemic antibiotic (IV) compared with systemic antibiotic (IV).

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 1 Systemic antibiotic (IV) compared with systemic antibiotic (IV).

1.1 Peristomal infection

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV) Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 4.2

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV).

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV).

Open in table viewer
Comparison 5. Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

1

68

Odds Ratio (M‐H, Fixed, 95% CI)

15.78 [1.90, 130.86]

Analysis 5.1

Comparison 5 Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Comparison 5 Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Open in table viewer
Comparison 6. Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

1

62

Odds Ratio (M‐H, Fixed, 95% CI)

15.63 [1.84, 133.09]

Analysis 6.1

Comparison 6 Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Comparison 6 Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Risk of bias graph: review authors' judgements about each risk of bias 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.

Comparison 1 Systemic antibiotic (IV) compared with placebo, Outcome 1 Peristomal infection.
Figuras y tablas -
Analysis 1.1

Comparison 1 Systemic antibiotic (IV) compared with placebo, Outcome 1 Peristomal infection.

Comparison 2 Systemic antibiotic (IV) compared with no intervention, Outcome 1 Peristomal infection.
Figuras y tablas -
Analysis 2.1

Comparison 2 Systemic antibiotic (IV) compared with no intervention, Outcome 1 Peristomal infection.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 1 Peristomal infection.
Figuras y tablas -
Analysis 3.1

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 1 Peristomal infection.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 2 Allocation concealment.
Figuras y tablas -
Analysis 3.2

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 2 Allocation concealment.

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 3 Sponsorship.
Figuras y tablas -
Analysis 3.3

Comparison 3 Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic, Outcome 3 Sponsorship.

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 1 Systemic antibiotic (IV) compared with systemic antibiotic (IV).
Figuras y tablas -
Analysis 4.1

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 1 Systemic antibiotic (IV) compared with systemic antibiotic (IV).

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV).
Figuras y tablas -
Analysis 4.2

Comparison 4 Systemic antibiotic compared with systemic antibiotic, Outcome 2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV).

Comparison 5 Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.
Figuras y tablas -
Analysis 5.1

Comparison 5 Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Comparison 6 Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.
Figuras y tablas -
Analysis 6.1

Comparison 6 Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic, Outcome 1 Peristomal infection.

Comparison 1. Systemic antibiotic (IV) compared with placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

8

586

Odds Ratio (M‐H, Fixed, 95% CI)

0.34 [0.22, 0.53]

Figuras y tablas -
Comparison 1. Systemic antibiotic (IV) compared with placebo
Comparison 2. Systemic antibiotic (IV) compared with no intervention

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

3

623

Odds Ratio (M‐H, Fixed, 95% CI)

0.30 [0.17, 0.53]

Figuras y tablas -
Comparison 2. Systemic antibiotic (IV) compared with no intervention
Comparison 3. Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.36 [0.26, 0.50]

2 Allocation concealment Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.47 [0.34, 0.65]

2.1 adequate allocation concealment

8

554

Odds Ratio (M‐H, Fixed, 95% CI)

0.58 [0.38, 0.88]

2.2 unclear/inadequate concealment

4

717

Odds Ratio (M‐H, Fixed, 95% CI)

0.34 [0.21, 0.58]

3 Sponsorship Show forest plot

12

1271

Odds Ratio (M‐H, Fixed, 95% CI)

0.36 [0.26, 0.50]

3.1 Trials with no sponsorship

10

962

Odds Ratio (M‐H, Fixed, 95% CI)

0.38 [0.25, 0.56]

3.2 Trials with sponsorship

2

309

Odds Ratio (M‐H, Fixed, 95% CI)

0.32 [0.18, 0.58]

Figuras y tablas -
Comparison 3. Systemic antibiotic (IV) compared with placebo/no intervention/skin antiseptic
Comparison 4. Systemic antibiotic compared with systemic antibiotic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Systemic antibiotic (IV) compared with systemic antibiotic (IV) Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Peristomal infection

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Systemic antibiotic (PEG) compared with systemic antibiotic (IV) Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Figuras y tablas -
Comparison 4. Systemic antibiotic compared with systemic antibiotic
Comparison 5. Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

1

68

Odds Ratio (M‐H, Fixed, 95% CI)

15.78 [1.90, 130.86]

Figuras y tablas -
Comparison 5. Systemic antibiotic (IV) compared with systemic antibiotic (IV) and skin antiseptic
Comparison 6. Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Peristomal infection Show forest plot

1

62

Odds Ratio (M‐H, Fixed, 95% CI)

15.63 [1.84, 133.09]

Figuras y tablas -
Comparison 6. Skin antiseptic compared with systemic antibiotic (IV) and skin antiseptic