NCT05488288RecruitingPhase 3
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 354 (estimated)
- First submitted
- 28 Jul 2022
- Start date
- 24 Jul 2023
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Obesity
- NCT number
- NCT05488288
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 354
- From 24 Jul 2023 to the primary completion date, 31 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous VH repair with mesh.
- Reoperation for BS (excepted previous adjustable gastric banding).
- Emergency surgery.
Other illness
- Ongoing abdominal skin infection.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of visceral and digestive surgery, Louis Mourier hospital, APHP Coordinator of this site? Confirm its status | Colombes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.