Status:
RECRUITING
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Ventral Hernia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 surgica...
Detailed Description
This is a prospective, multicentric, superiority, comparative randomized (1:1) single-blinded clinical trial with blinded assessment of the primary endpoint. Hypothesis for the study: abdominal ventr...
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 between 1 cm and 4 cm, on abdominopelvic CT-scan without contrast injection.
- Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.
- Request for BS approved by health insurance authorities.
- Written informed consent from patient.
Exclusion Criteria:
- Previous VH repair with mesh.
- Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia).
- Decision of performing BS by laparotomy.
- Reoperation for BS (excepted previous adjustable gastric banding).
- Ongoing abdominal skin infection.
- Emergency surgery.
- ASA (American Society of Anesthesiologists) score>3.
- Ongoing pregnancy or breast-feeding.
- Patient not covered by social insurance.
- Patient under legal guardianship.
- Patient already included in a clinical trial on hernia recurrence.
Key Trial Info
Start Date :
July 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT05488288
Start Date
July 24 2023
End Date
January 1 2030
Last Update
August 31 2023
Active Locations (1)
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1
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
Colombes, France, 92025