Loop Ileostomy Closure.Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site in the Abdominal Wall. A Prospective Randomised Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 12
- 主要终点
- Number of participants with postoperative stoma site hernia
研究概览
简要总结
There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions:
- The choice of anastomotic method - does it influence the postoperative course?
- The use of a prophylactic mesh when closing the stoma site - will there be less hernias?
详细描述
Postoperative complications after closure of a temporary loop ileostomy after rectal cancer surgery are common. In this study the investigators propose the hypothesis that a stapled anastomotic technique will decrease postoperative small bowel obstruction and a mesh closure of the stoma site in the abdominal wall will decrease hernia formation.
All patients will be randomized to stapled or hand-sewn anastomosis. The randomization to mesh or suture closure of the abdominal wall is optional.
The stapled anastomotic technique is performed by the use of a linear staple device and the hand-sewn technique with a running seromuscular monofilament suture.
The stoma site has two options and will be closed either by the use of mesh (lightweight), positioned under the muscle (retromuscular), or just by long-lasting suture. The anterior fascia of the rectus as well as the skin are closed by the use of running monofilament longlasting sutures, the latter in a pursestring procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •loop ileostomy after rectal cancer surgery
- •loop ileostomy closure is permitted and possible according to clinical practice
排除标准
- •patient unable to understand written or oral information
结局指标
主要结局
Number of participants with postoperative stoma site hernia
时间窗: 2 year
Herni postoperatively on the site of previous stoma detected within 2 years
Number of participants with postoperative bowel obstruction
时间窗: 30 days
Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray
次要结局
- Number of participants with postoperative complications(30 days)
- Postoperative Hospital stay(30 days)
研究者
Ulrik Lindforss
Associate professor
Karolinska University Hospital