Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-03-02 @ 12:07 AM
Study NCT ID:
NCT03556059
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2018-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'postoperative outcome after surgery next to the Clavien Dindo Classification'}], 'secondaryOutcomes': [{'measure': 'postoperative complications related to surgical procedure', 'timeFrame': '30 days after surgery', 'description': 'postoperative complications related to surgical procedure'}, {'measure': 'postoperative complications related to Edmonton Obesity Staging System', 'timeFrame': '30 days after surgery', 'description': 'postoperative complications related to Edmonton Obesity Staging System'}, {'measure': 'ASA related to Edmonton Obesity Staging System', 'timeFrame': 'prior to surgery', 'description': 'ASA related to Edmonton Obesity Staging System'}, {'measure': 'Edmonton Obesity Staging System related to length of postoperative stay', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related to length of postoperative stay'}, {'measure': 'Edmonton Obesity Staging System related to readmission', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related to readmission'}, {'measure': 'Edmonton Obesity Staging System related gender', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related gender'}, {'measure': 'Edmonton Obesity Staging System related to surgical procedure', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related to surgical procedure'}, {'measure': 'postoperative complications related to ASA', 'timeFrame': '30 days after surgery', 'description': 'postoperative complications related to ASA'}, {'measure': 'postoperative complications related to gender', 'timeFrame': '30 days after surgery', 'description': 'postoperative complications related to gender'}, {'measure': 'age related to postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'age related to postoperative complications'}, {'measure': 'Body Mass Index related to postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'Body Mass Index related to postoperative complications'}, {'measure': 'Edmonton Obesity Staging System related to age', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related to age'}, {'measure': 'Edmonton Obesity Staging System related to Body Mass Index', 'timeFrame': '30 days after surgery', 'description': 'Edmonton Obesity Staging System related to Body Mass Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EOSS', 'Obesity and metabolic surgery', 'postoperative outcome', 'procedure selection'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '19188927', 'type': 'RESULT', 'citation': 'Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes (Lond). 2009 Mar;33(3):289-95. doi: 10.1038/ijo.2009.2. Epub 2009 Feb 3.'}, {'pmid': '21838602', 'type': 'RESULT', 'citation': 'Kuk JL, Ardern CI, Church TS, Sharma AM, Padwal R, Sui X, Blair SN. Edmonton Obesity Staging System: association with weight history and mortality risk. Appl Physiol Nutr Metab. 2011 Aug;36(4):570-6. doi: 10.1139/h11-058. Epub 2011 Aug 14.'}, {'pmid': '21844111', 'type': 'RESULT', 'citation': 'Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.'}, {'pmid': '22002510', 'type': 'RESULT', 'citation': 'Gill RS, Karmali S, Sharma AM. The potential role of the Edmonton obesity staging system in determining indications for bariatric surgery. Obes Surg. 2011 Dec;21(12):1947-9. doi: 10.1007/s11695-011-0533-8. No abstract available.'}, {'pmid': '27317606', 'type': 'RESULT', 'citation': 'Chiappetta S, Stier C, Squillante S, Theodoridou S, Weiner RA. The importance of the Edmonton Obesity Staging System in predicting postoperative outcome and 30-day mortality after metabolic surgery. Surg Obes Relat Dis. 2016 Dec;12(10):1847-1855. doi: 10.1016/j.soard.2016.02.042. Epub 2016 Mar 2.'}, {'pmid': '31264178', 'type': 'DERIVED', 'citation': 'Chiappetta S, Stier C, Weiner RA; members of StuDoQ|MBE of Deutsche Gesellschaft fur Allgemein- und Viszeralchirurgie/StuDoQ. The Edmonton Obesity Staging System Predicts Perioperative Complications and Procedure Choice in Obesity and Metabolic Surgery-a German Nationwide Register-Based Cohort Study (StuDoQ|MBE). Obes Surg. 2019 Dec;29(12):3791-3799. doi: 10.1007/s11695-019-04015-y.'}]}, 'descriptionModule': {'briefSummary': 'The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.\n\nThe aim of this study is to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.', 'detailedDescription': 'All patients in Germany, who underwent Sleeve Gastrectomy, Roux-en Y Gastric Bypass and Mini/One anastomosis Gastric Bypass as a primary procedure for severe obesity, are prospectively registered in the German register StuDoQ MBE.\n\nPreoperative EOSS by Sharma et al. will be applied to all patients, who were operated between Februar 2015 and July 2017 by two different evaluators. Data collection will include the following: gender, age, body mass index, mobility, comorbidities, ASA score (American Society of Anesthesiologists score) perioperative complications next to Clavien Dindo, readmission rates and 30 - day mortality. Follow-up will be investigated in all patients up to 1 month after surgery.\n\nComplications, readmission rates and 30 day mortality will be investigated in relation to EOSS and the surgical procedure performed, to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity\n\n\\-\n\nExclusion Criteria:\n\n* previous obesity surgery\n* previous surgery of the upper gastrointestinal tract in anamnesis'}, 'identificationModule': {'nctId': 'NCT03556059', 'briefTitle': 'Procedure Selection in Obesity and Metabolic Surgery Based on EOSS', 'organization': {'class': 'OTHER', 'fullName': 'Sana Klinikum Offenbach'}, 'officialTitle': 'Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)', 'orgStudyIdInfo': {'id': 'FF 83_2/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RNYGB', 'description': 'The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity', 'interventionNames': ['Other: Role of EOSS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleeve', 'description': 'The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity', 'interventionNames': ['Other: Role of EOSS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MGB/OAGB', 'description': 'The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity', 'interventionNames': ['Other: Role of EOSS']}], 'interventions': [{'name': 'Role of EOSS', 'type': 'OTHER', 'description': 'The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.', 'armGroupLabels': ['MGB/OAGB', 'RNYGB', 'Sleeve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63069', 'city': 'Offenbach', 'country': 'Germany', 'facility': 'Sana Klinikum Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}], 'overallOfficials': [{'name': 'Rudolf Weiner, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sana Klinikum Offenbach'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymous data will be published in a peer-reviewed journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sana Klinikum Offenbach', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, Principal Investigator, MD', 'investigatorFullName': 'Sonja Chiappetta, MD', 'investigatorAffiliation': 'Sana Klinikum Offenbach'}}}}