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

• ClinicalTrials.gov Identifier: NCT05488288
• Recruitment Status: Recruiting
• First Posted: August 4, 2022
• Last Update Posted: August 31, 2023
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 28, 2022
• First Posted Date: August 4, 2022
• Last Update Posted Date: August 31, 2023
• Actual Study Start Date: July 24, 2023
• Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2022)

Hernia recurrence rate, with or without surgical repair [ Time Frame: at 2 years ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 2, 2022)

• Hernia recurrence rate at 1 year [ Time Frame: at 1 year ]
  Hernia recurrence rate clinically
• Reoperation rate for recurrence at 2 years [ Time Frame: at 2 years ]
  Reoperation rate for recurrence, at 2 years after randomization with medical files.
• Strangulated hernia rate at 1 year [ Time Frame: at 1 year ]
  Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)
• Surgical site infection rate at 1 year [ Time Frame: at 1 year ]
  Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)
• Mesh bulging rate at 2 years [ Time Frame: 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 [ Time Frame: daily up to 90 days ]
  Postoperative morbidity rate (any complication in the 90 days after randomization).
• Postoperative mortality rate [ Time Frame: daily up to 90 days ]
  Postoperative mortality rate (any complication in the 90 days after randomization).
• Benefit-risk ratio [ Time Frame: at the end of the study ]
  Benefit-risk ratio (DOOR-RADAR score established by the scientific committee prior to the start of the study).
• Self-reported chronic pain [ Time Frame: at 3 months, 6 months, 1 year and 2 years ]
  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 [ Time Frame: at 3 months, 6 months, 1 year and 2 years ]
  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 [ Time Frame: at 3 months, 6 months, 1 year and 2 years ]
  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 [ Time Frame: at 2 years ]
  Cost will be calculated.
• Weight loss [ Time Frame: at 3 months, 6 months, 1 year and 2 years ]
  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 [ Time Frame: 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
• Official Title: Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Ventral Hernia

Intervention

• Procedure: Mesh repair
  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.
• Procedure: Suture repair
  The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.

Study Arms

• Experimental: Mesh group

  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.

  Intervention: Procedure: Mesh repair
• Active Comparator: Suture group

  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: Procedure: Suture repair

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 2, 2022): 354
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2030
• Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David MOSZKOWICZ, MD, PhD; +33 (0)1 47 60 66 02; david.moszkowicz@aphp.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05488288
• Other Study ID Numbers: APHP211049; 2023-A00658-37 ( Registry Identifier: IDRCB )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David MOSZKOWICZ, MD, PhD; Department of visceral and digestive surgery, Louis-Mourier hospital, APHP

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: August 2023