Reducing hernia risk after stoma closure with mesh
Reducing the Incidence of Incisional Hernia After Stoma Closure Using a PROphylactic MESH: a Single-blinded Randomized Controlled Trial (PROMESH TRIAL).
This study is testing if using a special mesh during the closure of stomas can help cancer patients avoid getting hernias.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT04510558 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether using a prophylactic non-absorbable mesh during the closure of ileostomies or colostomies can reduce the incidence of incisional hernias in cancer patients. It is a randomized controlled single-blinded study that will compare the one-year incidence of hernias in patients receiving mesh versus those who do not. The goal is to improve patient quality of life and reduce healthcare costs associated with hernia complications. The study is significant as it addresses a gap in existing research regarding the effectiveness of prophylactic mesh in this context.
Who should consider this trial
Good fit: Ideal candidates are adult patients who have undergone ileostomy or colostomy for digestive cancer and are scheduled for elective closure.
Not a fit: Patients with allergies to the mesh or those on immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rate of incisional hernias, enhancing patient recovery and quality of life.
How similar studies have performed: Preliminary studies have shown promising results with similar approaches, indicating a potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient * Ileostomy or colostomy performed during surgery for digestive cancer * Planned elective closure of ileostomy or colostomy * Informed written consent Exclusion Criteria: * Allergy to the mesh * Patients under corticosteroids or other immunosuppressive treatment * Inability/refusal to follow the procedures of the study
Where this trial is running
Geneva
- University Hospitals of Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Jeremy Meyer, MD, MD-PhD
- Email: jeremy.meyer@unige.ch
- Phone: +41795533182
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.