Actively Recruiting
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-08-31
354
Participants Needed
1
Research Sites
336 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 mesh versus suture repair in morbidly obese BS candidates on the following measures: - hernia recurrence at 1 year after randomization; - reoperation for hernia recurrence at 2 years after randomization; - strangulated hernia, surgical infection and mesh bulging at one year after randomization; - postoperative morbidity and mortality at 90 days after randomization; - benefit-risk ratio; - chronic pain at three months, six months, one year and two years after randomization; - quality of life during the two years after randomization; - incremental cost utility ratio; - short- and mid-term weight loss. To study if the efficacy of mesh versus suture VH repair differs according to the type and size of VH and to the surgical technique.
CONDITIONS
Official Title
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 60 years.
- Body Mass Index (BMI) ≥ 40 kg/m² or ≥ 35 kg/m² with at least one comorbidity that can improve after bariatric surgery.
- Body Mass Index (BMI) less than 50 kg/m².
- Primary or first recurrent incisional midline, umbilical, or epigastric ventral hernia with width between 1 cm and 4 cm confirmed by abdominopelvic CT scan.
- Planned sleeve gastrectomy or gastric bypass after multidisciplinary discussion.
- Bariatric surgery request approved by health insurance.
- Written informed consent provided.
You will not qualify if you...
- Previous ventral hernia repair with mesh.
- Other abdominal hernia types (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, groin hernia).
- Planned bariatric surgery by open laparotomy.
- Reoperation for bariatric surgery except previous adjustable gastric banding.
- Active abdominal skin infection.
- Emergency surgery situation.
- American Society of Anesthesiologists (ASA) score greater than 3.
- Pregnancy or breastfeeding.
- Not covered by social insurance.
- Under legal guardianship.
- Currently enrolled in another clinical trial on hernia recurrence.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
Colombes, France, 92025
Actively Recruiting
Research Team
D
David MOSZKOWICZ, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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