Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04469712
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2020-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-randomized Prospective Comparison Between SASI Bipartition and RYGB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D000082122', 'term': 'Internal Hernia'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-07-11', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight change', 'timeFrame': '3 to 60 months after surgery', 'description': 'Measured as percent of Excess Weight Loss (%EWL) using the following formula:\n\n((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100'}, {'measure': 'Waist size change', 'timeFrame': '3 to 60 months after surgery', 'description': 'Waist size (in cm)'}, {'measure': 'Medical and surgical complication', 'timeFrame': '3 to 60 months after surgery', 'description': 'According to Clavien-Dindo classification'}, {'measure': 'Operative time', 'timeFrame': 'During surgery', 'description': 'Expressed in minutes'}, {'measure': 'Hemoglobin', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l'}, {'measure': 'Albumin', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l'}, {'measure': 'Ferritin', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l'}, {'measure': 'Iron', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l'}, {'measure': 'Parathyroid hormone (PTH)', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L'}, {'measure': 'Vitamin B12', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l'}, {'measure': 'Vitamin D', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l'}], 'secondaryOutcomes': [{'measure': 'Fasting glycemia', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l'}, {'measure': 'HbA1c', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %'}, {'measure': 'Triglycerides', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l'}, {'measure': 'Cholesterol', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l'}, {'measure': 'HDL', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l'}, {'measure': 'LDL', 'timeFrame': 'before surgery up to 60 months after surgery', 'description': 'Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l'}, {'measure': 'Antidiabetic drugs', 'timeFrame': '3 to 60 months after surgery', 'description': 'Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.'}, {'measure': 'Antilipidemic drugs', 'timeFrame': '3 to 60 months after surgery', 'description': 'Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.'}, {'measure': 'Antihypertensive drugs', 'timeFrame': '3 to 60 months after surgery', 'description': 'Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.'}, {'measure': 'Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)', 'timeFrame': '3 to 60 months after surgery', 'description': 'Evolution of the use of Continuous Positive Airway Pressure will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of OSA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Bypass,', 'SASI Bipartition', 'Weight loss', 'GERD', 'Internal Hernia'], 'conditions': ['Obesity, Morbid', 'Metabolic Syndrome', 'Bariatric Surgery Candidate', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '28205037', 'type': 'BACKGROUND', 'citation': 'Aghajani E, Nergaard BJ, Leifson BG, Hedenbro J, Gislason H. The mesenteric defects in laparoscopic Roux-en-Y gastric bypass: 5 years follow-up of non-closure versus closure using the stapler technique. Surg Endosc. 2017 Sep;31(9):3743-3748. doi: 10.1007/s00464-017-5415-2. Epub 2017 Feb 15.'}, {'pmid': '22609843', 'type': 'BACKGROUND', 'citation': 'Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.'}, {'pmid': '27545956', 'type': 'BACKGROUND', 'citation': 'Mahdy T, Al Wahedi A, Schou C. Efficacy of single anastomosis sleeve ileal (SASI) bypass for type-2 diabetic morbid obese patients: Gastric bipartition, a novel metabolic surgery procedure: A retrospective cohort study. Int J Surg. 2016 Oct;34:28-34. doi: 10.1016/j.ijsu.2016.08.018. Epub 2016 Aug 19.'}, {'pmid': '24441436', 'type': 'BACKGROUND', 'citation': 'Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.'}, {'pmid': '27387692', 'type': 'BACKGROUND', 'citation': 'Shah K, Johnny Nergard B, Stray Frazier K, Geir Leifsson B, Aghajani E, Gislason H. Long-term effects of laparoscopic Roux-en-Y gastric bypass on metabolic syndrome in patients with morbid obesity. Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1449-1456. doi: 10.1016/j.soard.2016.03.017. Epub 2016 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.', 'detailedDescription': 'The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary.\n\nPatients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery.\n\nResults on weight loss, comorbidities resolution, complications, and need of supplements are registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients approved for bariatric surgery at Bariatric Clinic, Aleris Hospital, Norway', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)\n\nExclusion Criteria:\n\n* Mental diseases\n* Drug addiction\n* Alcoholic\n* Malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04469712', 'briefTitle': 'Non-randomized Prospective Comparison Between SASI Bipartition and RYGB', 'organization': {'class': 'OTHER', 'fullName': 'Aleris Hospital'}, 'officialTitle': 'Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)', 'orgStudyIdInfo': {'id': '66095'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SASI Bipartition', 'description': 'Subjects submitted to SASI Bipartition', 'interventionNames': ['Procedure: SASI Bipartition']}, {'label': 'Roux-en-Y gastric bypass', 'description': 'Subjects submitted to gastric bypass', 'interventionNames': ['Procedure: Gastric bypass']}], 'interventions': [{'name': 'SASI Bipartition', 'type': 'PROCEDURE', 'otherNames': ['Single-anastomosis Sleeve Ileal Bypass'], 'description': 'SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.', 'armGroupLabels': ['SASI Bipartition']}, {'name': 'Gastric bypass', 'type': 'PROCEDURE', 'otherNames': ['Roux-en-Y gastric bypass'], 'description': 'A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.', 'armGroupLabels': ['Roux-en-Y gastric bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0264', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Aleris Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Ebrahim Aghajani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aleris Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The results of the study will be published in a scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aleris Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastrointestinal Surgeon, PhD, Principal investigator', 'investigatorFullName': 'Ebrahim Aghajani', 'investigatorAffiliation': 'Aleris Hospital'}}}}