Using mesh to prevent hernias after stoma closure in rectal cancer patients
Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
This study is testing if using a special mesh during stoma closure surgery can help prevent hernias in patients with rectal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Blokhin's Russian Cancer Research Center Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05939687 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of polypropylene mesh in preventing hernias after stoma closure in patients with colorectal cancer. Participants will be randomly assigned to receive either mesh or non-mesh repair techniques during their stoma closure surgery. The study will follow participants for two years to assess the incidence of parastomal hernias, wound infections, and overall quality of life. The trial will include 142 patients in total, with a focus on comparing outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are patients with colorectal cancer who have undergone stoma placement and are scheduled for stoma closure.
Not a fit: Patients with distant metastases, significant comorbidities, or acute inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of hernias following stoma closure, improving recovery and quality of life for patients.
How similar studies have performed: Previous studies have shown promising results with mesh use in hernia prevention, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Absence of distant metastases (M0) * ECOG (Eastern Cooperative Oncology Group) status 0-2 * completed course of adjuvant treatment * Absence of acute inflammatory parastomal complications * Integrity of colorectal anastomosis Exclusion Criteria: * Inability to obtain consent to participate * Synchronous and metachronous malignant neoplasms * Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system * Parastomal inflammation and other conditions that increase the risk of postoperative complications * Pregnancy * HIV infection
Where this trial is running
Moscow
- N.N.Blokhin Russian Cancer Research Center — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Sergey Gordeyev, D.Sc.
- Email: ss.netoncology@gmail.com
- Phone: 9104501213
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.