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New treatment option for Ventral Hernia
Official title Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05488288
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Colombes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.