Comparing methods for closing loop ileostomies after rectal cancer surgery
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Locations | 11 sites (Gothenburg and 10 other locations) |
| Trial ID | NCT02669992 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone rectal cancer surgery and have a temporary loop ileostomy that is ready for closure.
Not a fit: Patients who are unable to understand the study information or have contraindications for ileostomy closure will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gothenburg and 10 other locations
- 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)
Study contacts
- Principal investigator: Ulrik Lindforss, A.P — Karolinska University Hospital
- Study coordinator: Pontus Gustafsson, MD
- Email: pontus.gustafsson@gotland.se
- Phone: +46703272152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.