[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476772":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":55,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mesh group","EXPERIMENTAL","ventral hernia repair with non absorbable mesh placement concomitant to bariatric procedure (sleeve gastrectomy or by-pass).\n\nIn 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.",[13],"Procedure: Mesh repair",{"label":15,"type":16,"description":17,"interventionNames":18},"Suture group","ACTIVE_COMPARATOR","suture repair of ventral hernia concomitant to bariatric procedure (sleeve gastrectomy or by-pass).\n\nIn this group, the hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.",[19],"Procedure: Suture repair",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Suture repair","The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.",[15],[32],{"name":33,"affiliation":34,"role":35},"David MOSZKOWICZ, MD, PhD","Department of visceral and digestive surgery, Louis-Mourier hospital, APHP","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+33 (0)1 47 60 66 02","david.moszkowicz@aphp.fr",[42],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Department of visceral and digestive surgery, Louis Mourier hospital, APHP","RECRUITING","Colombes","92025","France","FR",{"type":50,"coordinates":51},"Point",[52,53],2.25404,48.91882,{"lat":53,"lon":52},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100476772","phase-3-bariatric-surgery-with-mesh-repair-of-ventral-hernia-a-randomized-controlled-trial-100476772",false,"NCT05488288","Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial","Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial","BeSURE","Inclusion Criteria:\n\n* Patients between 18 and 60 years.\n* Body Mass Index (BMI) ≥ 40 kg\u002Fm² or ≥ 35 kg\u002Fm² associated with at least one comorbidity that can improve after BS.\n* Body Mass Index (BMI) \\\u003C 50 kg\u002Fm².\n* Primary or first recurrent incisional midline VH, umbilical or epigastric, width between 1 cm and 4 cm, on abdominopelvic CT-scan without contrast injection.\n* Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.\n* Request for BS approved by health insurance authorities.\n* Written informed consent from patient.\n\nExclusion Criteria:\n\n* Previous VH repair with mesh.\n* Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia).\n* Decision of performing BS by laparotomy.\n* Reoperation for BS (excepted previous adjustable gastric banding).\n* Ongoing abdominal skin infection.\n* Emergency surgery.\n* ASA (American Society of Anesthesiologists) score\\>3.\n* Ongoing pregnancy or breast-feeding.\n* Patient not covered by social insurance.\n* Patient under legal guardianship.\n* Patient already included in a clinical trial on hernia recurrence.","ALL","18 Years","60 Years",{"count":69,"type":70},354,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","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.\n\nAs 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.",[76],"Ventral Hernia",[76,78,79,23,80],"Bariatric surgery","Obesity","Suture","2023-08-30",{"date":83,"type":84},"2023-08-31","ACTUAL",{"date":86,"type":84},"2023-07-24",{"date":88,"type":70},"2030-01",{"name":5,"class":6},1]