NCT02669992

Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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: 1. The choice of anastomotic method - does it influence the postoperative course? 2. The use of a prophylactic mesh when closing the stoma site - will there be less hernias?

Detailed description

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.

Conditions

• Rectal Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Stapled or Hand-sewn anastomosis	Randomization between stapled or hand-sewn anastomosis
PROCEDURE	Mesh or suture stoma site closure	Randomization between suture or Mesh closure of the stoma site

Timeline

• Start date: 2015-06-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2016-02-01
• Last updated: 2023-01-26

Locations

11 sites across 1 country: Sweden