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.
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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?
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• loop ileostomy after rectal cancer surgery
• loop ileostomy closure is permitted and possible according to clinical practice
Locations
Other Locations
Sweden
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
RECRUITING
Gothenburg
Centralsjukhuset Karlstad
RECRUITING
Karlstad
Sunderby Sjukhus
RECRUITING
Luleå
Lycksele lasarett
RECRUITING
Lycksele
Norrtälje sjukhus
RECRUITING
Norrtälje
Östersunds sjukhus
RECRUITING
Östersund
Skellefteå lasarett
RECRUITING
Skellefteå
Danderyds sjukhus
RECRUITING
Stockholm
Karolinska universitetssjukhuset
RECRUITING
Stockholm
Norrlands Universitets Sjukhus
RECRUITING
Umeå
Region Gotland
RECRUITING
Visby
Contact Information
Primary
Pontus Gustafsson, MD
pontus.gustafsson@gotland.se
+46703272152
Time Frame
Start Date: 2015-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 400
Treatments
Experimental: Stapled anastomosis
Stapled anastomosis by the use of commercially available linear stapler device
Active_comparator: Hand-sewn anastomosis
Hand-sewn by the use of a resorbable monofilament suture
Experimental: Abdominal wall mesh closure
Closure by the use of a mesh low-weight net device
Active_comparator: Abdominal wall suture closure
Closure by the use of slowly absorbing monofilament suture
Related Therapeutic Areas
Sponsors
Leads: Karolinska University Hospital