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Trial Title:
Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
NCT ID:
NCT05939687
Condition:
Neoplasms Malignant
Rectal Cancer
Hernia Incisional
Surgery
Conditions: Official terms:
Rectal Neoplasms
Neoplasms
Hernia
Incisional Hernia
Conditions: Keywords:
Rectal cancer
mesh
stoma-site hernia
prevention
surgery
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1:1 electronic randomisation
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
mesh
Description:
We'll use mesh repair for prevention of stoma-site hernias in the study group.
Arm group label:
mesh
Other name:
polypropylene mesh
Intervention type:
Procedure
Intervention name:
non-mesh
Description:
We'll use the layered ligature suturing of the abdominal wall without mesh implantation
in the control group.
Arm group label:
non-mesh
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.
Detailed description:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
N.N.Blokhin Russian Cancer Research Center
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Sergey S Gordeyev, PhD
Phone:
9104501213
Phone ext:
007
Email:
ss.netoncology@gmail.com
Start date:
June 5, 2023
Completion date:
December 1, 2028
Lead sponsor:
Agency:
Blokhin's Russian Cancer Research Center
Agency class:
Other
Source:
Blokhin's Russian Cancer Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05939687
