Status:

RECRUITING

Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Ventral Hernia

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

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 surgica...

Detailed Description

This is a prospective, multicentric, superiority, comparative randomized (1:1) single-blinded clinical trial with blinded assessment of the primary endpoint. Hypothesis for the study: abdominal ventr...

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.

Key Trial Info

Start Date :

July 24 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2030

Estimated Enrollment :

354 Patients enrolled

Trial Details

Trial ID

NCT05488288

Start Date

July 24 2023

End Date

January 1 2030

Last Update

August 31 2023

Active Locations (1)

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1

Department of visceral and digestive surgery, Louis Mourier hospital, APHP

Colombes, France, 92025