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Spots Global Cancer Trial Database for Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?

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Trial Identification

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

Official Title: 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.

Study ID: NCT02669992

Conditions

Rectal Neoplasm

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Östersunds sjukhus, Östersund, , Sweden

Contact Details

Name: Ulrik Lindforss, A.P

Affiliation: Karolinska University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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