Ventral HerniaPhase 3BeSURENCT05488288
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
A Phase 3 study testing Mesh repair and Suture repair in people with Ventral Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Mesh repair and Suture repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2023to Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
Colombes, 92025
About this study
Official title: Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Ventral Hernia
- Being tested
- Mesh repair, Suture repair
- Keywords
- Ventral Hernia, Bariatric surgery, Obesity, Mesh repair, Suture
- Medical subject headings
- Hernia, Ventral, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh repairProcedure or surgery
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 repairProcedure or surgery
The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Suture repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 2 years
Secondary outcomes (14)
Hernia recurrence rate at 1 year
Hernia recurrence rate clinically
Measured: at 1 year
Reoperation rate for recurrence at 2 years
Reoperation rate for recurrence, at 2 years after randomization with medical files.
Measured: at 2 years
Strangulated hernia rate at 1 year
Strangulated hernia rate (requiring emergent surgery), at 1 year after randomization (medical files)
Measured: at 1 year
Surgical site infection rate at 1 year
Surgical site infection rate (superficial or deep), at 1 year after randomization (medical files)
Measured: 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.
Measured: at 2 years
Postoperative morbidity rate
Postoperative morbidity rate (any complication in the 90 days after randomization).
Measured: daily up to 90 days
Postoperative mortality rate
Postoperative mortality rate (any complication in the 90 days after randomization).
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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')
Measured: at 3 months, 6 months, 1 year and 2 years
Incremental cost utility ratio
Cost will be calculated.
Measured: 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).
Measured: 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).
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start24 Jul 2023
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David MOSZKOWICZ, MD, PhD, Principal investigator, Department of visceral and digestive surgery, Louis-Mourier hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488288
- Sponsor's protocol ID
- APHP211049
- Other IDs
- 2023-A00658-37
- Acronym
- BeSURE
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05488288
- Acronym / sponsor ID
- BeSURE / APHP211049
- Conditions
- Ventral Hernia
- Keywords
- Ventral Hernia, Bariatric surgery, Obesity, Mesh repair, Suture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh group | Experimental | Procedure: Mesh repairventral 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 group | Active comparator | Procedure: Suture repairsuture 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh repairAbdominal 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 or surgery | Mesh group |
| Suture repairThe hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture. | Procedure or surgery | Suture group |
Primary outcome
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.
14 secondary outcomes
Hernia recurrence rate at 1 year
Time frame: at 1 year
Reoperation rate for recurrence at 2 years
Time frame: at 2 years
Strangulated hernia rate at 1 year
Time frame: at 1 year
Surgical site infection rate at 1 year
Time frame: at 1 year
Mesh bulging rate at 2 years
Time frame: at 2 years
Postoperative morbidity rate
Time frame: daily up to 90 days
Postoperative mortality rate
Time frame: daily up to 90 days
Benefit-risk ratio
Time frame: at the end of the study
Self-reported chronic pain
Time frame: at 3 months, 6 months, 1 year and 2 years
Score of quality of life
Time frame: at 3 months, 6 months, 1 year and 2 years
Pain evaluation
Time frame: at 3 months, 6 months, 1 year and 2 years
Incremental cost utility ratio
Time frame: at 2 years
Weight loss
Time frame: at 3 months, 6 months, 1 year and 2 years
Hernia recurrence rate at 2 years
Time frame: at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David MOSZKOWICZ, MD, PhD principal investigator
Department of visceral and digestive surgery, Louis-Mourier hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesh repair and Suture repair in people with Ventral Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David MOSZKOWICZ, MD, PhD (+33 (0)1 47 60 66 02, david.moszkowicz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence rate, with or without surgical repair (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.