NCT05488288 Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
| NCT ID | NCT05488288 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Ventral Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2023-07-24 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 354 participants in total. It began in 2023-07-24 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
David MOSZKOWICZ, MD, PhD
PRINCIPAL INVESTIGATOR
Department of visceral and digestive surgery, Louis-Mourier hospital, APHP
Frequently Asked Questions
Who can join the NCT05488288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Ventral Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05488288 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 354 participants.
Is NCT05488288 currently recruiting?
Yes, NCT05488288 is actively recruiting participants. Contact the research team at david.moszkowicz@aphp.fr for enrollment information.
Where is the NCT05488288 trial being conducted?
This trial is being conducted at Colombes, France.
Who is sponsoring the NCT05488288 clinical trial?
NCT05488288 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is David MOSZKOWICZ, MD, PhD at Department of visceral and digestive surgery, Louis-Mourier hospital, APHP. The trial plans to enroll 354 participants.