Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
RECRUITING
Colombes
Contact Information
Primary
David MOSZKOWICZ, MD, PhD
david.moszkowicz@aphp.fr
+33 (0)1 47 60 66 02
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2030-01
Participants
Target number of participants: 354
Treatments
Experimental: Mesh group
ventral hernia repair with non absorbable mesh placement concomitant to bariatric procedure (sleeve gastrectomy or by-pass).~In this group, the repair technique and the type of mesh are left to the choice of the center, as there are no strong data to demonstrate which technique is the best for VH repair in this population.
Active_comparator: Suture group
suture repair of ventral hernia concomitant to bariatric procedure (sleeve gastrectomy or by-pass).~In this group, the hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov