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ID02669992

Comparing Stapled and Hand-sewn Methods for Closing Loop Ileostomy After Rectal Cancer Surgery and Studying Mesh Versus Suture for Stoma Site Closure

Led by Karolinska University Hospital · Updated on 2023-01-26

400

Participants Needed

11

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying complications after closing a temporary loop ileostomy in patients who had surgery for rectal cancer. The study aims to answer two main questions whether the choice of anastomotic method affects recovery after surgery, and if using a mesh to close the stoma site can reduce hernias. This is a prospective randomized trial involving multiple centers to explore these surgical techniques. Participants are randomly assigned to receive either a stapled anastomosis using a linear staple device or a hand-sewn anastomosis with a running monofilament suture. Additionally, there is an optional randomization to close the stoma site either with a lightweight mesh placed under the muscle or with a long-lasting suture. The skin and fascia are closed with running monofilament sutures, including a pursestring technique for the skin. During the study, researchers will monitor participants for postoperative bowel obstruction within 30 days and for stoma site hernias over 2 years. They will also assess other complications and hospital stay length within 30 days. Participants will undergo follow-up visits to evaluate these outcomes and ensure proper recovery. The total participation timeline includes short-term and long-term monitoring to capture relevant surgical results.

CONDITIONS

Brief Title

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

Research Team

P

Pontus Gustafsson, MD

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