Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 232
- 主要终点
- Fistula closure
研究概览
简要总结
This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.
详细描述
At present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. In the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. However, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. This study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test
排除标准
- •HIV infection,
- •concomitant bladder stone(s),
- •one or more ureters outside of the bladder,
- •urethrovaginal fistula,
- •multiple fistulas (more than one),
- •dye leak / fistulous leak present at end of surgical procedure,
- •radiation-induced fistula,
- •fistula caused by cancer or infection (such as lymphogranuloma venereum),
- •continence procedures being performed (such as pubovaginal sling),
- •rectovaginal fistula,
- •pregnancy,
- •fistula breakdown of greater than 2cm identified on postoperative dye test.
结局指标
主要结局
Fistula closure
时间窗: 3 months post-repair
Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak
次要结局
- Urinary continence(3 months post-repair)
- Closure and continence at hospital discharge(Date of discharge (7-28 days post-repair))
- Complications(Duration of hospitalization (minimum 7 days, maximum 28 days post-repair))
研究者
Steven Shephard
Fistula Surgeon
Evangel VVF Centre