Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT02792166
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-06', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term Safety Assessment', 'timeFrame': '30 days', 'description': 'To evaluate feasibility and short-term safety of SADI-S, we will assess operative parameters (procedure time, inadvertent injuries, need for conversion to laparotomy, and transfusion of blood products) and 30-day postoperative adverse events (length of stay, superficial/deep surgical site infection, leak, venous thromboembolism (VTE), need for reintervention and readmission).'}, {'measure': 'Weight loss', 'timeFrame': '5 years', 'description': '%EWL and change in BMI as compared to preoperative reference values'}], 'secondaryOutcomes': [{'measure': 'Long-term Morbidity Assessment', 'timeFrame': '5 years', 'description': 'Postoperatively at 1, 6, 12 months and yearly thereafter for 5 years both groups will be compared for incidence of long-term morbidities including frequency of bowel movements, fat malabsorption, micronutrient and protein-calorie malnutrition, need for supplemental nutrition, internal/incisional herniation, and worsening versus de novo GERD.\n\nAt each visit protein (albumin, total protein) and vitamin/micronutrient levels (calcium, magnesium, iron, zinc, copper, selenium, vitamins A/E/D/K/B1/B6/B12) will be monitored using respective blood tests.'}, {'measure': 'Remission of T2DM', 'timeFrame': '5 years', 'description': "The presence of T2DM will be diagnosed according to the American Diabetes Association's current criteria:\n\n1. HbA1C ≥6.5 percent, OR\n2. FPG ≥126 mg/dL (7.0 mmol/L), OR\n3. 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT, OR\n4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L)"}, {'measure': 'Resolution/Improvement in other obesity related comorbidities', 'timeFrame': '5 years', 'description': 'Hypertension, Dyslipidemia, Obstructive sleep apnea, NAFLD/NASH'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '5 years', 'description': 'Quality of life status will be assessed using the SF-36 questionnaire at each follow-up visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'Metabolic syndrome', 'Metabolic surgery', 'Bariatric surgery', 'SADI', 'BPD-DS'], 'conditions': ['Obesity', 'Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '20798995', 'type': 'RESULT', 'citation': 'Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.'}, {'pmid': '26048517', 'type': 'RESULT', 'citation': 'Sanchez-Pernaute A, Rubio MA, Cabrerizo L, Ramos-Levi A, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. 2015 Sep-Oct;11(5):1092-8. doi: 10.1016/j.soard.2015.01.024. Epub 2015 Feb 7.'}, {'pmid': '22963820', 'type': 'RESULT', 'citation': 'Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.'}, {'pmid': '25543309', 'type': 'RESULT', 'citation': 'Sanchez-Pernaute A, Rubio MA, Conde M, Arrue E, Perez-Aguirre E, Torres A. Single-anastomosis duodenoileal bypass as a second step after sleeve gastrectomy. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):351-5. doi: 10.1016/j.soard.2014.06.016. Epub 2014 Jul 10.'}, {'pmid': '18040751', 'type': 'RESULT', 'citation': 'Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.'}, {'pmid': '37864735', 'type': 'DERIVED', 'citation': 'Andalib A, Safar A, Bouchard P, Demyttenaere S, Court O. Single Anastomosis Duodenal Switch versus Classic Duodenal Switch: Long-term Outcomes from a Prospective Comparative Cohort Study. Obes Surg. 2023 Dec;33(12):3951-3961. doi: 10.1007/s11695-023-06900-z. Epub 2023 Oct 21.'}, {'pmid': '33158766', 'type': 'DERIVED', 'citation': 'Andalib A, Bouchard P, Alamri H, Bougie A, Demyttenaere S, Court O. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S): short-term outcomes from a prospective cohort study. Surg Obes Relat Dis. 2021 Feb;17(2):414-424. doi: 10.1016/j.soard.2020.09.015. Epub 2020 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America.\n\nInterestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide.\n\nCommon reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure.\n\nSingle anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients.\n\nThis project has three specific aims:\n\n1. To evaluate feasibility and short-term safety of SADI-S.\n2. To evaluate short and long-term beneficial outcomes.\n3. To evaluate and compare long-term morbidity.', 'detailedDescription': 'The prevalence of morbid obesity in Canada has risen almost 5 fold in the past three decades. Surgery remains the cornerstone of treatment of obesity and related comorbidities such as type-2 diabetes. Bariatric/metabolic procedures can be classified into 2 main categories: a) those that cause restriction, and b) those that add a malabsorptive component to restriction. Currently sleeve gastrectomy (SG), which is a purely restrictive operation, is the most frequently performed procedure in North America.\n\nInterestingly, combined restrictive/malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion with duodenal switch (BPD-DS) are more effective procedures when compared to purely restrictive ones. Moreover, the conventional BPD-DS procedure has been shown to be significantly more effective than RYGB in achieving durable weight loss and resolving comorbidities such as type-2 diabetes. Despite superior outcomes, the performance of BPD-DS is highly institution dependant and comprises less than 5% of the annual bariatric procedures performed worldwide.\n\nCommon reservations against BPD-DS are related to the side effects of the procedure, and include frequent bowel movements, flatulence, fat, micronutrient and protein malnutrition. Furthermore, longer operative times and surgical technical challenges are also reasons for lower prevalence of the BPD-DS procedure.\n\nSingle anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) is a modification of the conventional BPD-DS that potentially addresses many of these concerns. In addition, it is a suitable second-stage or salvage procedure for severely obese patients with inadequate weight loss or resolution of obesity-related comorbidities after SG. Despite showing excellent results of up to 5 years with acceptable postoperative morbidity, all the literature on SADI-S originates from a single center and has not been compared directly with BPD-DS. Hence, the investigators aim to evaluate the feasibility, safety, and postoperative outcomes of SADI-S as it compares to conventional BPD-DS in morbidly obese patients. Our project has three specific aims:\n\n1. To evaluate feasibility and short-term safety of SADI-S. The investigators will assess operative parameters (e.g. procedure time, inadvertent injuries, need for conversion to laparotomy, and transfusion of blood products) and 30-day postoperative adverse events (e.g. length of stay, superficial/deep surgical site infection, leak, venous thromboembolism (VTE), need for reintervention and readmission).\n2. To evaluate short and long-term beneficial outcomes. The investigators will evaluate and compare excess weight loss, resolution of type-2 diabetes and other comorbidities, and changes in quality of life at 1, 6, 12 months and yearly thereafter for both groups.\n3. To evaluate and compare long-term morbidity. The investigators will evaluate and compare both groups at 6, 12 months and yearly thereafter following surgery for long-term morbidities (e.g. frequency of bowel movements, fat malabsorption, micronutrient and protein-calorie malnutrition, need for supplemental nutrition, internal/incisional hernia, and gastro-esophageal reflux).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipants must meet ALL of the following inclusion criteria:\n\n* Age ≥18 years and ≤60 years\n* Fulfill criteria for bariatric surgery as coined by National Institutes of Health\n* Give written informed consent\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria at the time of the baseline visit are excluded from the study:\n\n* Presence of the following baseline comorbidities:\n* Congestive heart failure (CHF),\n* Chronic kidney disease (CKD) stage 3-5 (or GFR \\<60 ml/min per 1.73 m2),\n* Inflammatory bowel disease (IBD),\n* Pulmonary hypertension (PHTN),\n* Cirrhosis.\n* Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease\n* Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. ≥2 missed appointments without a valid justification)"}, 'identificationModule': {'nctId': 'NCT02792166', 'briefTitle': 'Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): A Prospective Cohort Study', 'orgStudyIdInfo': {'id': '15-588 MUHC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BPD-DS', 'description': 'BPD-DS involves creating a sleeve gastrectomy and creation of a Roux-en-Y bypass involving a Roux limb (150cm) which is anastomosed to the transected first-stage of the duodenum and a short common channel (100cm).', 'interventionNames': ['Procedure: BPD-DS']}, {'type': 'EXPERIMENTAL', 'label': 'SADI-S', 'description': 'SADI-S involves creating a sleeve gastrectomy but simplifies the bypass part of the BPD-DS by a single anastomosis of a loop of jejunum at 250cm from the ileocecal valve (longer common channel) to the transected first-stage of the duodenum instead of the Roux-en-Y construct.', 'interventionNames': ['Procedure: SADI-S']}], 'interventions': [{'name': 'BPD-DS', 'type': 'PROCEDURE', 'otherNames': ['Bariatric/metabolic surgery'], 'description': 'Biliopancreatic Diversion with Duodenal Switch', 'armGroupLabels': ['BPD-DS']}, {'name': 'SADI-S', 'type': 'PROCEDURE', 'otherNames': ['Bariatric/metabolic surgery'], 'description': 'Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy', 'armGroupLabels': ['SADI-S']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Amin Andalib, MD MSc FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MSc FRCSC', 'investigatorFullName': 'Amin Andalib', 'investigatorAffiliation': 'McGill University'}}}}