跳至主要内容
临床试验/NCT00981539
NCT00981539Unknown不适用

Do Preoperative Enemas Prevent Complications in Vaginal Pelvic Reconstructive Surgery?

Illinois Urogynecology, Ltd.3 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
310
试验地点
3
主要终点
wound infection rate

研究概览

简要总结

Traditionally, many gynecologic surgeons have asked patients to perform a cleansing enema the night before a vaginal surgery done to repair pelvic organ prolapse (dropped bladder, dropped uterus). The belief is that there is then less or no stool present at the vaginal incision and less chance of infection of the wound by bowel bacteria. However, not all surgeons follow this practice. There is no evidence in the medical literature if one way is better than the other. In this study, patients scheduled for vaginal surgery to correct prolapse will be randomly assigned to perform an enema or not to perform an enema.

详细描述

The factors to be measured will be wound infection rates, and need to cleanse an incision of escaped stool.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female, AND
  • undergoing vaginal surgery for prolapse.

排除标准

  • pregnant women,
  • age younger than eighteen,
  • male sex, OR
  • concurrent abdominal surgery.

结局指标

主要结局

wound infection rate

时间窗: 6 weeks post op

次要结局

  • rate of contamination of surgical field by stool during surgery(day of surgery)

研究者

发起方
Illinois Urogynecology, Ltd.
申办方类型
Other

研究点 (3)

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