Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT01754194
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2012-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maria.young@medtronic.com', 'phone': '+353 (0)1 4381611', 'title': 'Maria Young - Clinical Research Manager', 'organization': 'Medtronic MITG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'OPTIMIZE Study was an outcome study conducted OUS and designed without specifying which products could be used (standard of care, not necessarily using Covidien products). As per CIP, AEs were not collected during the study (and not differentiated Serious vs other AEs). Complications are categorized as type and number in the Outcome Measure section', 'eventGroups': [{'id': 'EG000', 'title': 'Procedure Type I', 'description': 'Gastric Sleeve Resection', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Procedure Type II', 'description': 'Roux-en-Y Gastric Bypass', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type I', 'description': 'Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type II', 'description': 'Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '3', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.', 'unitOfMeasure': 'Score*months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '13', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.', 'unitOfMeasure': 'Score*months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '47', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.', 'unitOfMeasure': 'Score*months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Excess Weight Loss (EWL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '58', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.\n\nThe formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight \\[lbs\\] - IBW \\[lbs\\]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight.', 'unitOfMeasure': 'Percentage EWL*month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Resource Utilization - Durantion of Sugery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '83.2', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '135.9', 'spread': '51.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Resource Utilization - Recovery Time From Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '51.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'OG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'classes': [{'title': 'Wound infection', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Disorder of emptying stomach/increased, new reflux', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Secondary haemorrhage, intra-abdominal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Anastomotic leak', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dumping syndrome', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Intra-abdominal abscess', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anastomotic stenosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Symptomatic cholelithiasis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 Days', 'description': 'Incidence of procedural and post-procedural complications through 30 days post-op.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'FG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': '293 adults were enrolled from 17 Mentor (performed at least 50 procedures) and Mentee (performed less than 50 procedures) bariatric German referral centres. They were stratified for laparoscopic sleeve gastrectomies and Roux en Y gastric bypass (ideally 50:50). First participant enrolled April 2012 Last participant enrolled October 2013.', 'preAssignmentDetails': 'Use or preference of surgical procedure was at the discretion of the surgeon. For each patient, the study consisted of three phases: Screening/Baseline; Surgery; Post-operative observation for up to 12 months. Data were gathered per SoC (Standard of Care) at each of the three study phases.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection\n\nGastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection'}, {'id': 'BG001', 'title': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass\n\nRoux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (Kgs)', 'classes': [{'categories': [{'measurements': [{'value': '140.8', 'spread': '20.6', 'groupId': 'BG000'}, {'value': '132.3', 'spread': '20.2', 'groupId': 'BG001'}, {'value': '137.2', 'spread': '20.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kgs', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (kg/m^2)', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of Insurance (Public/Private)', 'classes': [{'title': 'Private Health Insurance', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}, {'title': 'Public Health Insurance', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2012-12-18', 'resultsFirstSubmitDate': '2016-08-03', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-12', 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)', 'timeFrame': '12 Months', 'description': 'The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.'}, {'measure': 'Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)', 'timeFrame': '12 months', 'description': 'The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.'}, {'measure': 'Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)', 'timeFrame': '12 months', 'description': 'The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.'}], 'secondaryOutcomes': [{'measure': 'Excess Weight Loss (EWL)', 'timeFrame': '12 Months', 'description': 'EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.\n\nThe formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight \\[lbs\\] - IBW \\[lbs\\]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight.'}, {'measure': 'Health Resource Utilization - Durantion of Sugery', 'timeFrame': '12 Months'}, {'measure': 'Health Resource Utilization - Recovery Time From Surgery', 'timeFrame': '12 months'}, {'measure': 'Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization', 'timeFrame': '12 Months'}, {'measure': 'Surgical Complications', 'timeFrame': '30 Days', 'description': 'Incidence of procedural and post-procedural complications through 30 days post-op.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Sleeve', 'Gastric Bypass', 'Roux en Y', 'Morbid Obesity', 'Laparoscopy'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '30187421', 'type': 'DERIVED', 'citation': 'Wolter S, Dupree A, ElGammal A, Runkel N, Heimbucher J, Izbicki JR, Mann O, Busch P. Mentorship Programs in Bariatric Surgery Reduce Perioperative Complication Rate at Equal Short-Term Outcome-Results from the OPTIMIZE Trial. Obes Surg. 2019 Jan;29(1):127-136. doi: 10.1007/s11695-018-3495-2.'}]}, 'descriptionModule': {'briefSummary': 'Study objectives:\n\n1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery\n2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.', 'detailedDescription': 'The objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as obese and eligible for weight loss surgery (BMI\\>40; or BMI\\>35 with co-morbidities) and the following insurance approval status (Kostenubernahmeantrag): approved.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged from 18 to 65 years of age, inclusive\n* BMI \\> 40 or BMI \\> 35 with co-morbidities\n* Eligible for weight-loss surgery\n* Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery\n* Insurance approval status: approved\n* Written informed consent\n\nExclusion Criteria:\n\n* BMI \\> 55\n* Planned two-stage procedures\n* Prior bariatric procedures (including gastric banding)\n* Serious mental or physical co-morbidities at the discretion of the Investigator\n* Insurance approval status: rejected'}, 'identificationModule': {'nctId': 'NCT01754194', 'acronym': 'OPTIMIZE', 'briefTitle': 'Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'An Observational Study in Morbidly Obese Patients to Evaluate Laparoscopic Gastric Sleeve Resections and Roux-en-Y Gastric Bypass Surgery in Clinical and Health-Economic Terms', 'orgStudyIdInfo': {'id': 'COVMBSG0167'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Procedure Type 1', 'description': 'Gastric Sleeve Resection', 'interventionNames': ['Procedure: Gastric Sleeve Resection']}, {'label': 'Procedure Type 2', 'description': 'Roux-en-Y Gastric Bypass', 'interventionNames': ['Procedure: Roux-en-Y Gastric Bypass']}], 'interventions': [{'name': 'Gastric Sleeve Resection', 'type': 'PROCEDURE', 'description': 'Laparoscopic Gastric Sleeve Resection', 'armGroupLabels': ['Procedure Type 1']}, {'name': 'Roux-en-Y Gastric Bypass', 'type': 'PROCEDURE', 'description': 'Laparoscopic Roux-en-Y Gastric Bypass', 'armGroupLabels': ['Procedure Type 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Cannstatt', 'country': 'Germany', 'facility': 'Krankenhaus Bad Cannstatt', 'geoPoint': {'lat': 48.8048, 'lon': 9.2145}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Bundeswehr Krankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Franziskus Hospital Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Bremerhaven', 'country': 'Germany', 'facility': 'BHV-Reinikenheide', 'geoPoint': {'lat': 53.55357, 'lon': 8.57553}}, {'city': 'Dachau', 'country': 'Germany', 'facility': 'Amperklinikum Dachau', 'geoPoint': {'lat': 48.26, 'lon': 11.43402}}, {'city': 'Emmendingen', 'country': 'Germany', 'facility': 'Kreiskrankenhaus Emmendingen', 'geoPoint': {'lat': 48.12096, 'lon': 7.85359}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinik Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Herne', 'country': 'Germany', 'facility': 'Ev. Krankenhaus Herne', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'city': 'Itzehoe', 'country': 'Germany', 'facility': 'Klinikum Itzehoe', 'geoPoint': {'lat': 53.92099, 'lon': 9.51529}}, {'city': 'Kassel', 'country': 'Germany', 'facility': 'Marienkrankenhaus Kassel', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'city': 'Lübbecke', 'country': 'Germany', 'facility': 'Krankenhaus Luebbecke', 'geoPoint': {'lat': 52.30699, 'lon': 8.61423}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'Sana Klinikum Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Diakoniekrankenhaus Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Neustadt', 'country': 'Germany', 'facility': 'Krankenhaus Hetzelstift Neustadt/Weinstraße', 'geoPoint': {'lat': 53.55196, 'lon': 9.98558}}, {'city': 'Saalfeld', 'country': 'Germany', 'facility': 'Thüringen-Kliniken "Georgius Agricola"', 'geoPoint': {'lat': 50.64826, 'lon': 11.36536}}, {'city': 'Schwäbisch Hall', 'country': 'Germany', 'facility': 'Diakonie-Klinikum Schwäbisch Hall', 'geoPoint': {'lat': 49.11127, 'lon': 9.73908}}, {'city': 'Villingen', 'country': 'Germany', 'facility': 'Schwarzwald Baar Klinikum Villingen', 'geoPoint': {'lat': 50.50447, 'lon': 8.93609}}, {'city': 'Winsen', 'country': 'Germany', 'facility': 'Krankenhaus Winsen', 'geoPoint': {'lat': 53.35753, 'lon': 10.21282}}], 'overallOfficials': [{'name': 'Oliver Mann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Hamburg Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}