Informations générales (source: ClinicalTrials.gov)
Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2023
janvier 2030
14 septembre 2025
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.
Etablissements
Critères
Tous
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.
- 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.
- 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.