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.