Rectal Neoplasm
Conditions
Keywords
Ileostomy
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.
Interventions
PROCEDUREStapled or Hand-sewn anastomosis
Randomization between stapled or hand-sewn anastomosis
PROCEDUREMesh or suture stoma site closure
Randomization between suture or Mesh closure of the stoma site
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* loop ileostomy after rectal cancer surgery * loop ileostomy closure is permitted and possible according to clinical practice
Exclusion criteria
* patient unable to understand written or oral information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative bowel obstruction | 30 days | Postoperative bowel obstruction within 30 Days, detected clinically or by the use of x-ray |
| Number of participants with postoperative stoma site hernia | 2 year | Herni postoperatively on the site of previous stoma detected within 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with postoperative complications | 30 days |
| Postoperative Hospital stay | 30 days |
Countries
Sweden
Contacts
Primary ContactPontus Gustafsson, MD
Outcome results
None listed