RecruitingNot ApplicableNCT02669992

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.


Sponsor

Karolinska University Hospital

Enrollment

400 participants

Start Date

Jun 1, 2015

Study Type

INTERVENTIONAL

Conditions

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?


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques for closing a temporary stoma (a surgically created opening in the belly that allows waste to exit through the abdominal wall instead of the rectum) after bowel surgery: using a stapling device versus sewing the bowel together by hand. **You may be eligible if...** - You have a temporary loop ileostomy (a type of stoma) that was created during previous bowel or rectal surgery - You are now ready to have the stoma reversed (closed) so your bowel can work normally again - You are in adequate health to undergo the closure surgery **You may NOT be eligible if...** - You are not a candidate for stoma closure at this time - You have serious complications from your previous surgery that make closure unsafe - You have an active infection near the stoma site - You have serious health conditions that make surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStapled or Hand-sewn anastomosis

Randomization between stapled or hand-sewn anastomosis

PROCEDUREMesh or suture stoma site closure

Randomization between suture or Mesh closure of the stoma site


Locations(11)

Sahlgrenska Universitetssjukhuset, Östra sjukhuset

Gothenburg, Sweden

Centralsjukhuset Karlstad

Karlstad, Sweden

Sunderby Sjukhus

Luleå, Sweden

Lycksele lasarett

Lycksele, Sweden

Norrtälje sjukhus

Norrtälje, Sweden

Östersunds sjukhus

Östersund, Sweden

Skellefteå lasarett

Skellefteå, Sweden

Danderyds sjukhus

Stockholm, Sweden

Karolinska universitetssjukhuset

Stockholm, Sweden

Norrlands Universitets Sjukhus

Umeå, Sweden

Region Gotland

Visby, Sweden

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NCT02669992


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