Tests mesh versus stitches to repair belly hernias during weight-loss surgery
Tests mesh or stitch repair of belly hernias in adults having weight-loss surgery.
Plain-language title generated from the registry record
Registry title: Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Key facts
- Where
- Colombes, FranceSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05488288, who can take part
Where in France
- Department of visceral and digestive surgery, Louis Mourier hospital, APHPColombes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05488288
- Record updated
- 31 August 2023
- Original description
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.Read full original descriptionShow less
Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
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.
Inclusion: 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: Previous VH repair with mesh; Reoperation for BS (excepted previous adjustable gastric banding); Emergency surgery; Ongoing abdominal skin infection; Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia); Decision of performing BS by laparotomy; 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.