Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
- Conditions
- Rectal Neoplasm
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- loop ileostomy after rectal cancer surgery
- loop ileostomy closure is permitted and possible according to clinical practice
- patient unable to understand written or oral information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- 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)
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
🇸🇪Goteborg, Sweden
Centralsjukhuset Karlstad
🇸🇪Karlstad, Sweden
Sunderby Sjukhus
🇸🇪Lulea, Sweden
Lycksele lasarett
🇸🇪Lycksele, Sweden
Norrtälje sjukhus
🇸🇪Norrtälje, Sweden
Skellefteå lasarett
🇸🇪Skellefteå, Sweden
Danderyds sjukhus
🇸🇪Stockholm, Sweden
Karolinska universitetssjukhuset
🇸🇪Stockholm, Sweden
Norrlands Universitets Sjukhus
🇸🇪Umea, Sweden
Region Gotland
🇸🇪Visby, Sweden
Scroll for more (1 remaining)Sahlgrenska Universitetssjukhuset, Östra sjukhuset🇸🇪Goteborg, SwedenPetra wieveg, MDContact