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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
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Ulrik Lindforss, A.P
Affiliation: Karolinska University Hospital
Role: PRINCIPAL_INVESTIGATOR