Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection
Recruiting
Phase 3
Interventional Study
Neoplasms Malignant
Rectal Cancer
Hernia Incisional
Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 142 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Other
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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.
Res…
Trial Locations
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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:
* I…
Contacts