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

Primary Purpose

Ventral Hernia

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mesh repair
Suture repair
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring Ventral Hernia, Bariatric surgery, Obesity, Mesh repair, Suture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of visceral and digestive surgery, Louis Mourier hospital, APHPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesh group

Suture group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hernia recurrence rate at 1 year
Hernia recurrence rate clinically
Reoperation rate for recurrence at 2 years
Reoperation rate for recurrence, at 2 years after randomization with medical files.
Strangulated hernia rate at 1 year
Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)
Surgical site infection rate at 1 year
Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)
Mesh bulging rate at 2 years
Mesh bulging rate, defined by a protrusion of the mesh through a fascial defect without hernia recurrence at CT-scan evaluation, at 2 years after randomization.
Postoperative morbidity rate
Postoperative morbidity rate (any complication in the 90 days after randomization).
Postoperative mortality rate
Postoperative mortality rate (any complication in the 90 days after randomization).
Benefit-risk ratio
Benefit-risk ratio (DOOR-RADAR score established by the scientific committee prior to the start of the study).
Self-reported chronic pain
Self-reported chronic pain, using the Visual Analogue Scale, at 3 months, 6 months, 1 year and 2 years after randomization
Score of quality of life
Using the EQ-5D-5L self-questionnaire EuroQol-5Dimensions-5Levels self-questionnaire (EQ-5D-5L value : -0.530 to 1.0 ; 1.0 indicates the best quality of life)
Pain evaluation
Using Visual Analogue Scale Visual Analogue Scale (0 to100; 0 represents 'no pain at all' whereas 100 represents 'the worst pain ever possible')
Incremental cost utility ratio
Cost will be calculated.
Weight loss
Short-term weight loss (percentage of excess weight loss at 3 and 6 months after the procedure); mid-term weight loss (percentage of excess weight loss at 1 and 2 years after the procedure).
Hernia recurrence rate at 2 years
Hernia recurrence rate at 2 years after randomization, by type (primary or incisional) and size of VH and by surgical technique (sublay/retromuscular or intraperitoneal or preperitoneal/underlay).

Full Information

First Posted
July 28, 2022
Last Updated
August 30, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05488288
Brief Title
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Acronym
BeSURE
Official Title
Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
January 2030 (Anticipated)
Study Completion Date
January 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 ventral hernia (VH) repair with mesh during bariatric surgery (BS) is more effective than suture repair in preventing VH recurrence. Secondarily, we expect that mesh repair would not increase the risk of surgical site infection. Population of study participants: Patients between 18 and 60 years, presenting with VH and scheduled for BS, excluding pregnant women and protected adults. All consecutive eligible patients will be invited to participate by visceral surgeons during preoperative consultations for BS. Included patients will be randomly assigned (1/1 ratio) to either mesh VH repair (intervention group) or suture VH repair (control group) by visceral surgeons at hospital admission (hospitalization or outpatient surgery) for BS and VH repair. Patients will be followed according to clinical guidelines for BS follow-up at M1, M3, M6, M9, M12, M18 and M24 after BS. There will be 29 surgical centers in France (digestive surgeons), targetting 354 eligible patients. Statistical analysis: An intention-to-treat statistical analysis will be performed at the end of the follow-up, when primary endpoint of all randomized patients will be documented. The analysis for the primary endpoint will consist in comparing proportions of hernia recurrence during the two years after surgery between the two arms, using a Chi2 test. An interim analysis is planned after half of the subjects finished their follow-up, in order to confirm the efficacy of the intervention arm, or alternatively its lack of efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia
Keywords
Ventral Hernia, Bariatric surgery, Obesity, Mesh repair, Suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
354 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesh group
Arm Type
Experimental
Arm Description
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.
Arm Title
Suture group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mesh repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Suture repair
Intervention Description
The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.
Primary Outcome Measure Information:
Title
Hernia recurrence rate, with or without surgical repair
Description
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.
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
Hernia recurrence rate at 1 year
Description
Hernia recurrence rate clinically
Time Frame
at 1 year
Title
Reoperation rate for recurrence at 2 years
Description
Reoperation rate for recurrence, at 2 years after randomization with medical files.
Time Frame
at 2 years
Title
Strangulated hernia rate at 1 year
Description
Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)
Time Frame
at 1 year
Title
Surgical site infection rate at 1 year
Description
Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)
Time Frame
at 1 year
Title
Mesh bulging rate at 2 years
Description
Mesh bulging rate, defined by a protrusion of the mesh through a fascial defect without hernia recurrence at CT-scan evaluation, at 2 years after randomization.
Time Frame
at 2 years
Title
Postoperative morbidity rate
Description
Postoperative morbidity rate (any complication in the 90 days after randomization).
Time Frame
daily up to 90 days
Title
Postoperative mortality rate
Description
Postoperative mortality rate (any complication in the 90 days after randomization).
Time Frame
daily up to 90 days
Title
Benefit-risk ratio
Description
Benefit-risk ratio (DOOR-RADAR score established by the scientific committee prior to the start of the study).
Time Frame
at the end of the study
Title
Self-reported chronic pain
Description
Self-reported chronic pain, using the Visual Analogue Scale, at 3 months, 6 months, 1 year and 2 years after randomization
Time Frame
at 3 months, 6 months, 1 year and 2 years
Title
Score of quality of life
Description
Using the EQ-5D-5L self-questionnaire EuroQol-5Dimensions-5Levels self-questionnaire (EQ-5D-5L value : -0.530 to 1.0 ; 1.0 indicates the best quality of life)
Time Frame
at 3 months, 6 months, 1 year and 2 years
Title
Pain evaluation
Description
Using Visual Analogue Scale Visual Analogue Scale (0 to100; 0 represents 'no pain at all' whereas 100 represents 'the worst pain ever possible')
Time Frame
at 3 months, 6 months, 1 year and 2 years
Title
Incremental cost utility ratio
Description
Cost will be calculated.
Time Frame
at 2 years
Title
Weight loss
Description
Short-term weight loss (percentage of excess weight loss at 3 and 6 months after the procedure); mid-term weight loss (percentage of excess weight loss at 1 and 2 years after the procedure).
Time Frame
at 3 months, 6 months, 1 year and 2 years
Title
Hernia recurrence rate at 2 years
Description
Hernia recurrence rate at 2 years after randomization, by type (primary or incisional) and size of VH and by surgical technique (sublay/retromuscular or intraperitoneal or preperitoneal/underlay).
Time Frame
at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David MOSZKOWICZ, MD, PhD
Phone
+33 (0)1 47 60 66 02
Email
david.moszkowicz@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David MOSZKOWICZ, MD, PhD
Organizational Affiliation
Department of visceral and digestive surgery, Louis-Mourier hospital, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
City
Colombes
ZIP/Postal Code
92025
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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