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

NCT02669992 · tracked via the Priya Life Science Sweden tracker

Sponsor

Karolinska University Hospital

Phase

Not applicable

Started

2015-06

Last updated

2023-01-26

Condition(s) studied

Rectal Neoplasm

Investigational drug(s) / intervention(s)

Stapled or Hand-sewn anastomosisMesh or suture stoma site closure

Stapled or Hand-sewn anastomosis: Randomization between stapled or hand-sewn anastomosis

Mesh or suture stoma site closure: Randomization between suture or Mesh closure of the stoma site

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (11)

Facility	City	Region	Status
Sahlgrenska Universitetssjukhuset, Östra sjukhuset	Gothenburg	Sweden	Recruiting
Centralsjukhuset Karlstad	Karlstad	Sweden	Recruiting
Sunderby Sjukhus	Luleå	Sweden	Recruiting
Lycksele lasarett	Lycksele	Sweden	Recruiting
Norrtälje sjukhus	Norrtälje	Sweden	Recruiting
Östersunds sjukhus	Östersund	Sweden	Recruiting
Skellefteå lasarett	Skellefteå	Sweden	Recruiting
Danderyds sjukhus	Stockholm	Sweden	Recruiting
Karolinska universitetssjukhuset	Stockholm	Sweden	Recruiting
Norrlands Universitets Sjukhus	Umeå	Sweden	Recruiting
Region Gotland	Visby	Sweden	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02669992 on ClinicalTrials.gov ↗ ← All trials in Sweden