NCT05488288

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P50-P75 for phase_3

Timeline
44mo left

Started Jul 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jul 2023Jan 2030

First Submitted

Initial submission to the registry

July 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6.4 years

First QC Date

July 28, 2022

Last Update Submit

August 30, 2023

Conditions

Ventral Hernia

Keywords

Ventral HerniaBariatric surgeryObesityMesh repairSuture

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence rate, with or without surgical repair

    Final diagnosis of hernia recurrence will be made by an endpoint committee of radiologists, blinded to the randomization arm (it is not possible to distinguish mesh from suture repair on CT-scans) on abdomino-pelvic CT-scan without contrast injection. Radiological hernia is defined as any protrusion of abdominal contents, including the anterior parietal peritoneum, visible as discontinuity of the fascial layers. In case of hernia recurrence requiring new VH repair during the study period (before the two years CT-scan evaluation), this will be considered as an event in intention-to-treat analysis.

    at 2 years

Secondary Outcomes (14)

  • Hernia recurrence rate at 1 year

    at 1 year

  • Reoperation rate for recurrence at 2 years

    at 2 years

  • Strangulated hernia rate at 1 year

    at 1 year

  • Surgical site infection rate at 1 year

    at 1 year

  • Mesh bulging rate at 2 years

    at 2 years

  • +9 more secondary outcomes

Study Arms (2)

Mesh group

EXPERIMENTAL

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.

Procedure: Mesh repair

Suture group

ACTIVE COMPARATOR

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.

Procedure: Suture repair

Interventions

Mesh repairPROCEDURE

Abdominal ventral hernia (VH) repair with mesh during bariatric surgery. 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.

Mesh group
Suture repairPROCEDURE

The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.

Suture group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify 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 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.

You may not qualify 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Colombes, 92025, France

RECRUITING

MeSH Terms

Conditions

Hernia, VentralObesity

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • David MOSZKOWICZ, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David MOSZKOWICZ, MD, PhD

CONTACT

+33 (0)1 47 60 66 02david.moszkowicz@aphp.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 4, 2022

Study Start

July 24, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

FR(1)