Comparing methods for closing loop ileostomies after rectal cancer surgery
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.
Run by Karolinska University Hospital · NCT02669992 · Data updated 2026-11-12
This study is testing whether using a stapled method or a hand-sewn method to close loop ileostomies after rectal cancer surgery leads to fewer complications, like blockages or hernias.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 11 sites (Gothenburg and 10 other locations) |
| Status | Recruiting |
| Started | June 2015 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | January 26, 2023 |
| Trial ID | NCT02669992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have undergone rectal cancer surgery and have a temporary loop ileostomy that is ready for closure.
✕Probably not a fit
Patients who are unable to understand the study information or have contraindications for ileostomy closure will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of different anastomotic techniques on postoperative outcomes following the closure of temporary loop ileostomies in patients who have undergone surgery for rectal cancer. Participants will be randomly assigned to receive either a stapled or hand-sewn anastomosis, with an optional randomization for the closure of the stoma site using either mesh or suture. The goal is to determine if the stapled method reduces complications such as small bowel obstruction and if the use of mesh decreases the incidence of hernias at the stoma site.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and reduced complications for patients undergoing ileostomy closure.
How similar studies have gone: Previous studies have shown varying results with different anastomotic techniques, but this specific comparison of stapled versus hand-sewn methods with mesh closure is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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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
Show 5 more locations
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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
Study contacts
- Principal investigator: Ulrik Lindforss, A.P — Karolinska University Hospital
- Study coordinator: Pontus Gustafsson, MD
- Email: pontus.gustafsson@gotland.se
- Phone: +46703272152
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.