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

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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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.

Conditions
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Rectal Neoplasm

Intervention / Treatment
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* Procedure: Stapled or Hand-sewn anastomosis
* Procedure: Mesh or suture stoma site closure


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stapled anastomosis<br>Stapled anastomosis by the use of commercially available linear stapler device | Procedure: Stapled or Hand-sewn anastomosis<br>* Randomization between stapled or hand-sewn anastomosis<br>|
| Active Comparator: Hand-sewn anastomosis<br>Hand-sewn by the use of a resorbable monofilament suture | Procedure: Stapled or Hand-sewn anastomosis<br>* Randomization between stapled or hand-sewn anastomosis<br>|
| Experimental: Abdominal wall mesh closure<br>Closure by the use of a mesh low-weight net device | Procedure: Mesh or suture stoma site closure<br>* Randomization between suture or Mesh closure of the stoma site<br>|
| Active Comparator: Abdominal wall suture closure<br>Closure by the use of slowly absorbing monofilament suture | Procedure: Mesh or suture stoma site closure<br>* Randomization between suture or Mesh closure of the stoma site<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative complications |  | 30 days | 
| Postoperative Hospital stay |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ileostomy