Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Recruiting now · Phase 3
Conditions studied: Neoplasms Malignant, Rectal Cancer, Hernia Incisional, Surgery
In brief
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.
Key facts
- Study ID
- NCT05939687
- Run by
- Blokhin's Russian Cancer Research Center
- People needed
- 142
- Starts
- 2023-06-05
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- N.N.Blokhin Russian Cancer Research Center — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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