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Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial

RecruitingPhase 3Ages 18 Years - 60 YearsAllAssistance Publique - Hôpitaux de Paris
NCT05488288 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dur

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mesh repair
  • Suture repair
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Where

1 site
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
Colombes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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