Actively Recruiting
Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
Led by Blokhin's Russian Cancer Research Center · Updated on 2024-08-07
142
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using polypropylene mesh during stoma closure can prevent hernias in patients with colorectal cancer. This phase III randomized trial aims to compare the benefits and risks of mesh versus no mesh repair following stoma closure. The study focuses on reducing hernia rates at the stoma site over a 2-year follow-up period, including assessing quality of life and surgical complications. Participants will be divided into two groups: one group will receive mesh repair using a sublay/interoblique technique to prevent hernias, while the other group will undergo standard stoma closure with layered suturing without mesh. The study includes 71 patients in each group, with stratification based on the size of the stoma-site hernia. During the study, participants will be monitored for hernia development over 2 years. Researchers will also assess surgical morbidity within 90 days after surgery and evaluate quality of life using the Hernia-Related Quality of Life Survey (HerQLes). Follow-up and assessments will help determine the potential benefits and harms of mesh use during stoma closure.
CONDITIONS
Brief Title
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- No distant metastases (M0)
- ECOG status 0-2
- Completed course of adjuvant treatment
- No acute inflammatory parastomal complications
- Integrity of colorectal anastomosis
You will not qualify if you...
- Unable to provide consent
- Synchronous or metachronous malignant neoplasms
- Significant cardiovascular, liver, kidney, or central nervous system diseases
- Parastomal inflammation or conditions increasing postoperative risk
- Pregnancy
- HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and immediate recovery period
Participants undergo stoma closure surgery with either mesh repair or standard layered suturing to prevent stoma-site hernias, followed by immediate post-operative care.
1 surgery visit (in-person) and immediate post-operative care
Duration - 90 days
Participants are monitored for surgical complications, wound infections, and quality of life after surgery.
Regular visits during 90 days post-surgery
Duration - 2 years
Participants are observed for hernia development and quality of life for up to 2 years after surgery.
Periodic visits over 2 years
Trial Site Locations
Total: 1 location
1
N.N.Blokhin Russian Cancer Research Center
Moscow, Russia, 115478
Actively Recruiting
Research Team
S
Sergey Gordeyev, D.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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