Bariatric surgery with mesh repair for ventral hernia
Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
This study is testing whether using a special mesh or traditional stitches for fixing a ventral hernia during weight loss surgery helps patients have better results and fewer problems afterward.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Colombes) |
| Trial ID | NCT05488288 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of ventral hernia repair using non-absorbable mesh versus traditional suture repair during bariatric surgery. It will involve patients aged 18 to 60 with a body mass index (BMI) of 35 or higher, who are scheduled for bariatric surgery and have a specific type of ventral hernia. Participants will be randomly assigned to one of the two repair methods and followed for two years to assess hernia recurrence and other postoperative outcomes. The study will take place across 29 surgical centers in France, with a total target of 354 patients.
Who should consider this trial
Good fit: Ideal candidates are morbidly obese patients aged 18 to 60 with a specific type of ventral hernia scheduled for bariatric surgery.
Not a fit: Patients with previous hernia repairs using mesh or those with other types of abdominal hernias may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hernia recurrence in patients undergoing bariatric surgery.
How similar studies have performed: Previous studies have shown promising results with mesh repair techniques in hernia surgeries, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Colombes
- Department of visceral and digestive surgery, Louis Mourier hospital, APHP — Colombes, France (Recruiting)
Study contacts
- Principal investigator: David MOSZKOWICZ, MD, PhD — Department of visceral and digestive surgery, Louis-Mourier hospital, APHP
- Study coordinator: David MOSZKOWICZ, MD, PhD
- Email: david.moszkowicz@aphp.fr
- Phone: +33 (0)1 47 60 66 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.