A randomised controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair.

Abstract

OBJECTIVE:

To test the hypothesis that intravenous antibiotics given intra-operatively reduce the failure rate of vesico-vaginal fistula repair.

DESIGN:

A single blind, randomised controlled trial.

SETTING:

A district hospital in Benin, West Africa.

POPULATION:

Seventy-nine women undergoing repair of an obstetric vesico-vaginal fistula by a single surgeon at Hopital Evangelique; two women had repeat operations.

METHODS:

Participants in the treatment group (n = 41) received ampicillin 500 mg intra-operatively. Controls (n = 40) received no prophylactic antibiotics.

MAIN OUTCOME MEASURES:

Failure of fistula closure and objective incontinence (a positive pad test) at hospital discharge. Secondary outcomes included febrile morbidity, other antibiotic use and urinary infection.

RESULTS:

Antibiotic prophylaxis did not reduce the odds of failed repair (OR 2.1 95% CI 0.75-6.1) or of objective incontinence (OR 1.9; 95% CI 0.72-5.1). The women in the antibiotic prophylaxis group received less post-operative antibiotics and had less urinary infections at day 10.

CONCLUSIONS:

Prophylactic antibiotics should not be used in vesico-vaginal fistulae repair in the developing world outside randomised controlled trials.

• Authors: A J Tomlinson, J G Thornton
• Journal: British journal of obstetrics and gynaecology (Br J Obstet Gynaecol) Vol. 105 Issue 4 Pg. 397-9 (Apr 1998) ISSN: 0306-5456 [Print] England
• PMID: 9609264 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Penicillins
• Ampicillin

Topics

• Ampicillin (therapeutic use)
• Antibiotic Prophylaxis (methods)
• Benin
• Female
• Humans
• Intraoperative Care
• Penicillins (therapeutic use)
• Reoperation
• Single-Blind Method
• Surgical Wound Infection (prevention & control)
• Treatment Failure
• Urinary Incontinence (etiology)
• Urinary Tract Infections (prevention & control)
• Vesicovaginal Fistula (surgery)
• Wound Healing