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

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.