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

Not Applicable

Recruiting

• Conditions: Rectal Neoplasm
• Interventions: Procedure: Stapled or Hand-sewn anastomosis; Procedure: Mesh or suture stoma site closure

• Registration Number: NCT02669992
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• loop ileostomy after rectal cancer surgery
• loop ileostomy closure is permitted and possible according to clinical practice

Exclusion Criteria

• patient unable to understand written or oral information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Hand-sewn anastomosis	Stapled or Hand-sewn anastomosis	Hand-sewn by the use of a resorbable monofilament suture
Abdominal wall mesh closure	Mesh or suture stoma site closure	Closure by the use of a mesh low-weight net device
Abdominal wall suture closure	Mesh or suture stoma site closure	Closure by the use of slowly absorbing monofilament suture
Stapled anastomosis	Stapled or Hand-sewn anastomosis	Stapled anastomosis by the use of commercially available linear stapler device

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative stoma site hernia	2 year	Herni postoperatively on the site of previous stoma detected within 2 years
Number of participants with postoperative bowel obstruction	30 days	Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray

Secondary Outcome Measures

Name	Time	Method
Number of participants with postoperative complications	30 days
Postoperative Hospital stay	30 days

Trial Locations

Locations (11)

Östersunds sjukhus; 🇸🇪 Östersund, Sweden

Sahlgrenska Universitetssjukhuset, Östra sjukhuset; 🇸🇪 Goteborg, Sweden

Centralsjukhuset Karlstad; 🇸🇪 Karlstad, Sweden

Sunderby Sjukhus; 🇸🇪 Lulea, Sweden

Lycksele lasarett; 🇸🇪 Lycksele, Sweden

Norrtälje sjukhus; 🇸🇪 Norrtälje, Sweden

Norrlands Universitets Sjukhus; 🇸🇪 Umea, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

Karolinska universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Region Gotland; 🇸🇪 Visby, Sweden

Skellefteå lasarett; 🇸🇪 Skellefteå, Sweden