Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 8:55 AM
Study NCT ID:
NCT02931292
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2016-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Decade of Sleeve Gastrectomy: Analysis of Short and Long-term Outcome of 562 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 562}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2016-10-09', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent excess body mass index loss (%EBMIL)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'calculated using formula: %EBMIL = \\[∆BMI / (initial BMI - 25)\\] x 100'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Definitions of glycemic outcomes after sleeve gastrectomy'}, {'measure': 'change on lipid profile', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Change on lipid profile before and after bariatric surgery was reported according to the Adult Treatment Panel III Guidelines, 2001, of the National Heart, Lung and Blood Institute as follows: no change, improvement in dislipidemia (defined as decrease in number or dose of lipid-lowering agents with equivalent control of dyslipidemia or improved control of lipids on equivalent medication) and remission (defined as normal lipid panel off medication).'}, {'measure': 'percent of complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Complications were evaluated under two headings. Major complications were defined as any complication that resulted in a prolonged hospital stay (beyond 7 days), reintervention, or reoperation. Minor complications were included everything else that is not included under major. They were further categorized as early if observed in 30 days or late if beyond 30 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleeve gastrectomy', 'laparoscopy', 'bariatric surgery', 'obesity surgery', 'metabolic surgery'], 'conditions': ['Morbid Obesity', 'Obesity', 'Diabetes', 'Dyslipidemia', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Obesity is a chronic disease and its treatment requires close follow-up to accurately assess the efficacy and durability of any treatment strategy. It is widely accepted that bariatric surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies.\n\nThe study objective was to ascertain efficacy of weight loss and complication rates in 562 consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.', 'detailedDescription': 'Obesity is a major healthcare problem reaching epidemic proportion and affecting people of all age (1). The only treatment that proven effective option for a significant substantial long-term weight loss and that cures or durably improves comorbidities is still bariatric surgery (2, 3). Because obesity is a chronic disease, it is widely accepted that to accurately assess the efficacy and durability of any type of bariatric surgery requires lifetime follow-up to assess for weight loss, co-morbidity changes, and nutritional deficiencies.\n\nDespite initially performed as a first part of the staged procedures, the laparoscopic sleeve gastrectomy (LSG) has since introduced as a stand-alone bariatric operation associated with good, short and mid-term weight loss and satisfactory complication rates when conducted in experienced hands. Although simplicity and the overall efficacy of the procedure supported by meta-analysis and systematic review (4, 5), there are still limited long-term outcome data (6). Due to publication bias or multiple controversies regarding the technique of LSG, some of the available data may have underreported which has also been resulted in questioning the long-term weight loss efficacy of the procedure.\n\nAlthough addressed by a recent consensus document,12 there are multiple controversies regarding the technique of LSG, and this may in part be what has led to the variable published results.\n\nThe study objective was to assess the long-term (≥ 5 years) as well as short (1 to ≤ 3 years) and mid-term (\\> 3 to \\< 5 years) results in regard to the BMI change, resolution of co-morbidities and complications in 562 consecutive morbidly obese patients undergoing LSG as a primary procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From Jun 2005 to Jun 2015, overall 562 consecutive morbidly obese patients admitted to the Hatem Hospital and Medical park Gaziantep Hospital that underwent sleeve gastrectomy for morbid obesity and/or its related co-morbidities were included to the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* underwent LSG for morbid obesity and related morbidities as a primary procedure\n\nExclusion Criteria:\n\n* previous history of obesity surgery'}, 'identificationModule': {'nctId': 'NCT02931292', 'acronym': 'SG', 'briefTitle': 'A Decade of Sleeve Gastrectomy: Analysis of Short and Long-term Outcome of 562 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical Park Gaziantep Hospital'}, 'officialTitle': 'A Decade of Sleeve Gastrectomy as a Single Bariatric/Metabolic Procedure: Analysis of Short and Long-term Outcome of 562 Patients', 'orgStudyIdInfo': {'id': 'MK-009-MO-SG1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleeve Gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'Laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Special care was given to the complete mobilization of the gastric fundus, with meticulous dissection of the posterior gastric wall from the left pillar. A 36-Fr calibration bougie was used. Resection started 2 to 6 cm from pylorus, and it was conducted upward to 1.5 cm from the angle of His, to avoid the "critical area." A gastric remnant of 60-80 mL volume (measured by administering methylene blue saline solution via nasogastric tube) was obtained.', 'armGroupLabels': ['Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehmet Kaplan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahcesehir University, BAU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Park Gaziantep Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harran University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Kaplan', 'investigatorAffiliation': 'Medical Park Gaziantep Hospital'}}}}