Bariatric surgery with mesh repair for ventral hernia
Official title: Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT05488288 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 354 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Colombes) |
| Status | Recruiting |
| Started | July 24, 2023 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | August 31, 2023 |
| Trial ID | NCT05488288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are morbidly obese patients aged 18 to 60 with a specific type of ventral hernia scheduled for bariatric surgery.
✕Probably not a fit
Patients with previous hernia repairs using mesh or those with other types of abdominal hernias may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with mesh repair techniques in hernia surgeries, suggesting potential success for this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Duramesh repair versus minimally invasive IPOM for high-risk umbilical hernia
This trial tests whether Duramesh repair can match the pain outcomes of minimally invasive IPOM in adults with high-risk umbilical or ventral hernias.
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Epidural vs. opioid-sparing pain control after complex ventral hernia repair
This trial tests whether an epidural for pain relief after transversus abdominis release hernia repair works better than a non‑opioid, abdominal wall numbing injection approach.
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Risk factors for mesh infection after abdominal wall reconstruction
This study tests which factors put adults at risk for mesh infection after abdominal wall reconstruction using different mesh types.
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Hernia Sac Flap Coverage of Mesh in Complex Bony-Edged Ventral Hernias
We’re testing whether using the patient’s own hernia sac as a living flap underneath the mesh helps healing after complex ventral hernia repair when part of the edge is bone.
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AGN-151607-DP to help close the belly wall after open midline ventral hernia repair
This trial tests whether a single intramuscular dose of AGN-151607-DP helps safely close the belly wall in adults having open midline ventral hernia repair.
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Intensive lifestyle intervention for patients undergoing ventral hernia repair
This study tests if a special program that helps people change unhealthy habits can reduce complications after surgery for ventral hernia repair.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.