Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 85

Using mesh to prevent hernias after stoma closure in rectal cancer patients

Official title: Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial

Run by Blokhin's Russian Cancer Research Center · NCT05939687 · Data updated 2026-11-12

This study is testing if using a special mesh during stoma closure surgery can help prevent hernias in patients with rectal cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment142 (estimated)
SponsorBlokhin's Russian Cancer Research Center
Academic / other
Locations1 site (Moscow)
StatusRecruiting
StartedJune 5, 2023
Main results expectedDecember 1, 2028
Study endsDecember 1, 2028
Registry record updatedAugust 7, 2024
Trial IDNCT05939687 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with colorectal cancer who have undergone stoma placement and are scheduled for stoma closure.

Probably not a fit

Patients with distant metastases, significant comorbidities, or acute inflammatory conditions may 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 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.

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 gone: Previous studies have shown promising results with mesh use in hernia prevention, suggesting potential for success in this trial.

Who can join: the full rules

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 it's running

  • N.N.Blokhin Russian Cancer Research Center
    Moscow, Russia
    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.