[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457916":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":75,"collaborators":78,"id":80,"slug":67,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":67,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":67,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":53,"whyStopped":67,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Laval University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"biliopancreatic diversion with duodenal switch","ACTIVE_COMPARATOR","Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)",[13],"Procedure: Standard duodenal switch",{"label":15,"type":16,"description":17,"interventionNames":18},"Single-anastomosis duodeno-ileal anastomosis","EXPERIMENTAL","Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)",[19],"Procedure: Single-anastomosis duodenal switch",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Standard duodenal switch","Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)",[9],[27],"BPD-DS",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Single-anastomosis duodenal switch","Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)",[15],[33],"SADI",[35],{"name":36,"affiliation":37,"role":38},"Laurent Biertho, MD","Institut universitaire de cardiologie et de pneumologie de Québec, University Laval","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Mélanie Nadeau, MSc","CONTACT","418-656-8711","3490","melanie.nadeau@criucpq.ulaval.ca",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Suzy Laroche","3841","suzy_laroche@ssss.gouv.qc.ca",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Institut Universitaire de Cardiologie et de Pneumologie de Québec","RECRUITING","Québec","Quebec","G1V 4G5","Canada",{"type":59,"coordinates":60},"Point",[61,62],-71.21454,46.81228,{"lat":62,"lon":61},[65,66,68,71,73],{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},{"name":36,"role":38,"phone":67,"phoneExt":67,"email":67},null,{"name":69,"role":70,"phone":67,"phoneExt":67,"email":67},"André Tchernof, PhD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":67,"phoneExt":67,"email":67},"Caroline Diorio, PhD",{"name":74,"role":70,"phone":67,"phoneExt":67,"email":67},"Andreanne Michaud, PhD",{"type":38,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"Laurent Biertho","Principal Investigator",[79],{"name":37,"class":6},"100457916",false,"NCT05242835","Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery","Inclusion Criteria:\n\n* had sleeve gastrectomy a minimum of 18 months before\n* still meet the NIH criteria for bariatric surgery (BMI≥35kg\u002Fm2 with major comorbidities or BMI≥40kg\u002Fm2) or patients with EWL\\\u003C50% or significant weight regain (≥20%EWL)\n\nExclusion Criteria:\n\n* general contra-indication for bariatric surgery\n* BMI\\\u003C35kg\u002Fm2\n* pregnancy\n* cirrhosis\n* abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease","ALL","18 Years","60 Years",{"count":89,"type":90},151,"ESTIMATED","INTERVENTIONAL",[93],"NA","Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.\n\nResearch Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.\n\nWith the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.",[96,97],"Obesity","Obesity, Morbid",[99],"Bariatric surgery","2025-12-01",{"date":102,"type":103},"2025-12-08","ACTUAL",{"date":105,"type":103},"2023-02-03",{"date":107,"type":90},"2027-03",{"name":5,"class":6},1]