Clinical trial Recruiting at 11 sites Interventional

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 typeInterventional
SexAll
Enrollment400 (estimated)
SponsorKarolinska University Hospital
Academic / other
Locations11 sites (Gothenburg and 10 other locations)
StatusRecruiting
StartedJune 2015
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedJanuary 26, 2023
Trial IDNCT02669992 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.