A randomised controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair
A randomised controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair
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DOI：
10.1111/j.1471-0528.1998.tb10122.x
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发表时间：
1998-04-01
期刊：
影响因子：
--
通讯作者：
Thornton, JG
中科院分区：
文献类型：
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作者：
Tomlinson, AJ;Thornton, JG
目的检验术中静脉注射抗生素是否能降低膀胱阴道瘘修补术的失败率这一假设。设计一项单盲、随机对照试验。地点：西非贝宁的一家地区医院。方法治疗组（n = 41）术中应用氨苄青霉素500 mg;对照组（n = 40）未接受预防性抗生素治疗。主要结果测量出院时瘘管闭合失败和客观尿失禁（尿垫试验阳性）。次要结果包括发热发病率，其他抗生素的使用和泌尿系infection.Results抗生素预防并没有减少失败的修复（OR 2.1，95%CI 0.75-6.1）或客观尿失禁（OR 1.9，95%CI 0.72-5.1）的几率。抗生素预防组术后抗生素使用量较少，术后第10天尿路感染发生率较低。结论在发展中国家，除随机对照试验外，不应在膀胱阴道瘘修补术中使用预防性抗生素。
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.