NCT05939687 Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
| NCT ID | NCT05939687 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Blokhin's Russian Cancer Research Center |
| Condition | Neoplasms Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2028-12-01 |
Trial Parameters
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Brief Summary
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.
Eligibility 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