Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBlokhin's Russian Cancer Research Center
About this trial
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 criteria
Qualifiers
Signed informed consent
Absence of distant metastases (M0)
ECOG (Eastern Cooperative Oncology Group) status 0-2
completed course of adjuvant treatment
Disqualifiers
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
Trial design
Treatments tested in this trial
- mesh
- non-mesh
Treatment groups
142 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov