Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05242835
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excess weight loss', 'timeFrame': '12 month', 'description': 'Percentage of excess weight loss mobilized in response to surgery'}], 'secondaryOutcomes': [{'measure': 'Peroperative complications', 'timeFrame': 'from baseline up to 60 months', 'description': 'Complications graded with Clavien classification'}, {'measure': 'Risk of malnutrition', 'timeFrame': 'from baseline to 60 months', 'description': 'Risk of malnutrition assessed through measurement of its risk being mild (albumin\\<35g\\\\L), moderate (albumin\\<30g/L) or severe (albumin\\<25g/L)'}, {'measure': 'Change in quality of life (SF-36)', 'timeFrame': 'from baseline to 60 months', 'description': '36-item short form survey evaluating quality of life on a scale form 0 to 100'}, {'measure': 'Change in quality of life (BAROS)', 'timeFrame': 'from baseline to 60 months', 'description': 'Bariatric Analyses and Reporting Outcomes System score form -7 to 9'}, {'measure': 'Change in quality of life (QLaval)', 'timeFrame': 'from baseline to 60 months', 'description': 'Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7'}, {'measure': 'Gastro-intestinal side effects', 'timeFrame': 'from baseline to 60 months', 'description': 'Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144'}, {'measure': 'Change in nutritional status (calcium)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of calcium (mmol/L)'}, {'measure': 'Change in nutritional status (ferritin)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of ferritin (ug/L)'}, {'measure': 'Change in nutritional status (TIBC)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of TIBC (umol/L)'}, {'measure': 'Change in nutritional status (iron)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of iron (umol/L)'}, {'measure': 'Change in nutritional status (prealbumin)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of prealbumin (g/L)'}, {'measure': 'Change in nutritional status (transferrin)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis transferrin (g/L)'}, {'measure': 'Change in nutritional status (vitamin A)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of vitamin A (umol/L)'}, {'measure': 'Change in nutritional status (vitamin D3)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis of vitamin D3 (nmol/L)'}, {'measure': 'Change in nutritional status (parathormone)', 'timeFrame': 'from baseline to 60 months', 'description': 'Change in nutritional status based on blood analysis parathormone (ng/L)'}, {'measure': 'Change in food intake', 'timeFrame': 'from baseline to 60 months', 'description': 'Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day)'}, {'measure': 'Change in eating behavior', 'timeFrame': 'from baseline to 60 months', 'description': 'Change of eating behavior using the Three-Factor Eating Questionnaire evaluating cognitive restraint of eating on a scale from 0 to 20, disinhibition on a scale from 0 to 16 and hunger on a scale from 0 to 15'}, {'measure': 'Change in food addiction', 'timeFrame': 'from baseline to 60 months', 'description': 'Change of eating behavior using the Yale Food Addiction Scale that includes a "symptom count" scale from 0 to 7 reflecting the number of addiction-like criteria endorsed and a dichotomous evaluation that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met'}, {'measure': 'Change in binge eating behavior', 'timeFrame': 'from baseline to 60 months', 'description': 'Change of eating behavior using the Binge Eating scale from 0 to 46'}, {'measure': 'Evolution of obesity related diseases', 'timeFrame': 'from baseline to 60 months', 'description': 'Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery'], 'conditions': ['Obesity', 'Obesity, Morbid']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had sleeve gastrectomy a minimum of 18 months before\n* still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL\\<50% or significant weight regain (≥20%EWL)\n\nExclusion Criteria:\n\n* general contra-indication for bariatric surgery\n* BMI\\<35kg/m2\n* pregnancy\n* cirrhosis\n* abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT05242835', 'briefTitle': 'Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery', 'orgStudyIdInfo': {'id': 'Second stage SADI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'biliopancreatic diversion with duodenal switch', 'description': 'Patient randomized for a the standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)', 'interventionNames': ['Procedure: Standard duodenal switch']}, {'type': 'EXPERIMENTAL', 'label': 'Single-anastomosis duodeno-ileal anastomosis', 'description': 'Patient randomized for a single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)', 'interventionNames': ['Procedure: Single-anastomosis duodenal switch']}], 'interventions': [{'name': 'Standard duodenal switch', 'type': 'PROCEDURE', 'otherNames': ['BPD-DS'], 'description': 'Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)', 'armGroupLabels': ['biliopancreatic diversion with duodenal switch']}, {'name': 'Single-anastomosis duodenal switch', 'type': 'PROCEDURE', 'otherNames': ['SADI'], 'description': 'Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)', 'armGroupLabels': ['Single-anastomosis duodeno-ileal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Suzy Laroche', 'role': 'CONTACT', 'email': 'suzy_laroche@ssss.gouv.qc.ca', 'phone': '418-656-8711', 'phoneExt': '3841'}, {'name': 'Laurent Biertho, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'André Tchernof, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline Diorio, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andreanne Michaud, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Mélanie Nadeau, MSc', 'role': 'CONTACT', 'email': 'melanie.nadeau@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3490'}, {'name': 'Suzy Laroche', 'role': 'CONTACT', 'email': 'suzy_laroche@ssss.gouv.qc.ca', 'phone': '418-656-8711', 'phoneExt': '3841'}], 'overallOfficials': [{'name': 'Laurent Biertho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Laurent Biertho', 'investigatorAffiliation': 'Laval University'}}}}