A Phase 3 interventional study of mesh and non-mesh in Neoplasms Malignant, Rectal Cancer and Hernia Incisional, sponsored by Blokhin's Russian Cancer Research Center. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Blokhin's Russian Cancer Research Center · Phase 3, Interventional, and Prevention
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.
This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs \<5 cm stoma-site hernia.
The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.
Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 142 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Blokhin's Russian Cancer Research Center is the lead sponsor of 33 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.
Procedure: mesh
In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.
Procedure: non-mesh
We'll use mesh repair for prevention of stoma-site hernias in the study group.
Also known as: polypropylene mesh
We'll use the layered ligature suturing of the abdominal wall without mesh implantation in the control group.
hernia rate
The rate of parastomal hernias after stoma closure for 2 years.
Time frame: 2 years
90 day surgical morbidity
Complications after stoma closure including hernias
Time frame: 90 days
Quality of life indicators by HerQLes scale
Quality of life as assessed by Hernia-Related Quality of Life Survey scale (HerQLes) at 30 days, 1 year and 2 years after stoma closure (higher scores are worse)
Time frame: 2 years
Plan to share: No
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Blokhin's Russian Cancer Research Center