Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
N.N.Blokhin Russian Cancer Research Center
RECRUITING
Moscow
Contact Information
Primary
Sergey Gordeyev, D.Sc.
ss.netoncology@gmail.com
9104501213
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 142
Treatments
Experimental: mesh
In these patients we will do sublay/interoblique repair for prevention of stoma-site hernias using a polypropylene mesh.
Active_comparator: non-mesh
In these patients we will close the stoma with standard layered ligature suturing of the abdominal wall without mesh implantation.
Related Therapeutic Areas
Sponsors
Leads: Blokhin's Russian Cancer Research Center

This content was sourced from clinicaltrials.gov