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

Ventral Hernia Clinical Trial

— BeSURE  

Official title:

Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488288
• Other study ID #: APHP211049
• Secondary ID: 2023-A00658-37
• Status: Recruiting
• Phase: Phase 3
• Start date: July 24, 2023
• Est. completion date: January 2030

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: David MOSZKOWICZ, MD, PhD
• Phone: +33 (0)1 47 60 66 02
• Email: david.moszkowicz[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Department of visceral and digestive surgery, Louis Mourier hospital, APHP	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hernia recurrence rate at 1 year	Hernia recurrence rate clinically	at 1 year
Secondary	Reoperation rate for recurrence at 2 years	Reoperation rate for recurrence, at 2 years after randomization with medical files.	at 2 years
Secondary	Strangulated hernia rate at 1 year	Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)	at 1 year
Secondary	Surgical site infection rate at 1 year	Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)	at 1 year
Secondary	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.	at 2 years
Secondary	Postoperative morbidity rate	Postoperative morbidity rate (any complication in the 90 days after randomization).	daily up to 90 days
Secondary	Postoperative mortality rate	Postoperative mortality rate (any complication in the 90 days after randomization).	daily up to 90 days
Secondary	Benefit-risk ratio	Benefit-risk ratio (DOOR-RADAR score established by the scientific committee prior to the start of the study).	at the end of the study
Secondary	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	at 3 months, 6 months, 1 year and 2 years
Secondary	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)	at 3 months, 6 months, 1 year and 2 years
Secondary	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')	at 3 months, 6 months, 1 year and 2 years
Secondary	Incremental cost utility ratio	Cost will be calculated.	at 2 years
Secondary	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).	at 3 months, 6 months, 1 year and 2 years
Secondary	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).	at 2 years