A Phase 3 interventional study of Mesh repair and Suture repair in Ventral Hernia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 354 is above the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.
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.
Time frame: at 2 years
Hernia recurrence rate at 1 year
Hernia recurrence rate clinically
Time frame: at 1 year
Reoperation rate for recurrence at 2 years
Reoperation rate for recurrence, at 2 years after randomization with medical files.
Time frame: at 2 years
Strangulated hernia rate at 1 year
Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)
Time frame: at 1 year
Surgical site infection rate at 1 year
Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)
Time frame: at 1 year
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.
Time frame: at 2 years
Postoperative morbidity rate
Postoperative morbidity rate (any complication in the 90 days after randomization).
Time frame: daily up to 90 days
Postoperative mortality rate
Postoperative mortality rate (any complication in the 90 days after randomization).
Time frame: daily up to 90 days
Benefit-risk ratio
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
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
Time frame: at 3 months, 6 months, 1 year and 2 years
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)
Time frame: at 3 months, 6 months, 1 year and 2 years
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')
Time frame: at 3 months, 6 months, 1 year and 2 years
Incremental cost utility ratio
Cost will be calculated.
Time frame: at 2 years
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).
Time frame: at 3 months, 6 months, 1 year and 2 years
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).
Time frame: at 2 years
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