NCT05939687RecruitingPhase 3
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study. Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- First submitted
- 3 Jul 2023
- Start date
- 5 Jun 2023
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Diseases
- Colorectal cancer
- NCT number
- NCT05939687
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 142
- From 5 Jun 2023 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- HIV infection
Other
- Inability to obtain consent to participate
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| N.N. Blokhin Russian Cancer Research Center Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.