Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- timing to return of bowel function
研究概览
简要总结
This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diverting loop ileostomy
- •undergoing evaluation for stoma takedown
排除标准
- •unable to perform consent
- •unable to perform stoma infusion
结局指标
主要结局
timing to return of bowel function
时间窗: 1-5 days
time to return of bowel function after stoma surgery
次要结局
- complications(2 weeks prior to surgery to 30 days post operatively)
- ease of stoma infusion(2 weeks prior to surgery to time of surgery)
研究者
Shanglei Liu
Assistant Professor of Surgery
University of California, San Diego