Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Recruiting · NCT05939687 · Interventional (participants receive a specific treatment) · Lead sponsor: Blokhin's Russian Cancer Research Center
View the official record on ClinicalTrials.gov →Interventions studied
meshnon-mesh
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- N.N.Blokhin Russian Cancer Research Center - Moscow, Russia