Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Recruiting
Phase 3
Interventional Study
Ventral Hernia
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 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 354 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
The primary objective of the study is to demonstrate that hernia recurrence (VH) repair with non absorbable mesh concomitant to Bariatric Surgery (BS) decreases the risk of VH, with or without surgical repair, during the first two years after BS when compared to VH suture repair without mesh.
As secondary objectives, the study aims to assess the impact of concomitant VH repair with non absorbable…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients between 18 and 60 years.
* Body Mass Index (BMI) ≥ 40 kg/m² or ≥ 35 kg/m² associated with at least one comorbidity that can improve after BS.
* Body Mass Index (BMI) \< 50 kg/m².
* Primary or first recurrent incisional midline VH, umbilical or epigastric, width betwee…
Contacts