PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 6
- 主要终点
- Stoma-related adverse events
研究概览
简要总结
Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.
排除标准
- •are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age <18 years, (4) inadequate ability to co-operate.
研究组 & 干预措施
Loop ileostomy
干预措施: Loop ileostomy (Procedure)
Loop colostomy
干预措施: Loop colostomy (Procedure)
结局指标
主要结局
Stoma-related adverse events
时间窗: Within 60 days from randomization
Stoma-related adverse events score by using Comprehensive Complication Index
次要结局
- Postoperative complications(Within 30 days from randomization)
- Postoperative complications after stoma closure(Within 30 days from stoma closure)
- Hospital-free days(Within 30 days from randomization)
- Quality of life(At 2 months from randomization)
- Kidney function change(Within 1 year from randomization)
研究者
Ville Sallinen
Adj. Professor
Helsinki University Central Hospital