Preventing hernias after reversing loop ileostomy
Prevention of Hernia After Loop Ileostomy Reversal
This study is testing whether using a special mesh can help prevent hernias in patients who have had their loop ileostomy reversed after rectal cancer surgery, compared to standard treatment without mesh.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 4 sites (Södertälje and 3 other locations) |
| Trial ID | NCT03720262 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using a retro muscular mesh versus standard treatment without mesh in preventing hernias after loop ileostomy reversal in patients who have undergone rectal cancer surgery. It is a prospective, double-blinded randomized trial aimed at addressing the significant morbidity associated with stoma reversal, particularly the development of hernias at the stoma site. The study will evaluate a non-heterogeneous group of patients to provide clearer insights into the best methods for hernia prevention following stoma closure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone low anterior resection for rectal cancer and are planned for stoma reversal.
Not a fit: Patients with recurrent cancer or those facing language barriers or cognitive disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hernias in patients undergoing stoma reversal, improving their quality of life.
How similar studies have performed: While there is limited scientific evidence supporting the routine use of prophylactic mesh, preliminary studies suggest potential benefits, indicating that this approach is novel and may provide valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal Exclusion Criteria: * Language barrier or cognitive disability * Recurrent cancer
Where this trial is running
Södertälje and 3 other locations
- Södertälje Hospital — Södertälje, Sweden (Recruiting)
- Stockholm South General Hospital — Stockholm, Sweden (Recruiting)
- Ersta Hospital — Stockholm, Sweden (Recruiting)
- Västmanland Hospital — Västerås, Sweden (Recruiting)
Study contacts
- Principal investigator: Åsa Hallqvist Everhov, MS, PhD — Stockholm South General Hospital
- Study coordinator: Åsa Hallqvist Everhov, MD, PhD
- Email: asa.hallqvist-everhov@sll.se
- Phone: +46702264127
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.