Actively Recruiting
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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