Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02607267
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2015-11-16', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative outcome related to EOSS', 'timeFrame': '30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'postoperative complications related to EOSS', 'timeFrame': '30 days after surgery'}, {'measure': 'readmission rates related to EOSS', 'timeFrame': '30 days after surgery'}, {'measure': 'age related to postoperative complications', 'timeFrame': '30 days after surgery'}, {'measure': 'BMI related to postoperative complications', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EOSS', 'Metabolic Surgery', 'postoperative outcome', '30 - day mortality'], 'conditions': ['Postoperative Complications', 'Other Complications of Other Bariatric Procedure']}, 'referencesModule': {'references': [{'pmid': '21838602', 'type': 'BACKGROUND', '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': 'BACKGROUND', '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': 'BACKGROUND', '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': '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.'}]}, '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. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.', 'detailedDescription': 'From October 2014 to December 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)), being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was applied to all patients by two different evaluators. Data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. Follow-up was performed in all patients up to 1 month after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '73 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing either LSG or LRYGB, being the first surgical treatment for severe obesity\n\nExclusion Criteria:\n\n* bariatric surgery in the anamnesis'}, 'identificationModule': {'nctId': 'NCT02607267', 'briefTitle': 'Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Sana Klinikum Offenbach'}, 'officialTitle': 'The Importance of the Edmonton Obesity Score System in Predicting Postoperative Outcome and 30 Day Mortality After Metabolic Surgery', 'orgStudyIdInfo': {'id': 'FF 83/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic Roux en Y Gastric Bypass', 'description': 'patients undergoing LRYGB, being the first surgical treatment for severe obesity', 'interventionNames': ['Other: LSG and LRYGB']}, {'label': 'laparoscopic Sleeve Gastrectomy', 'description': 'patients undergoing LSG, being the first surgical treatment for severe obesity', 'interventionNames': ['Other: LSG and LRYGB']}], 'interventions': [{'name': 'LSG and LRYGB', 'type': 'OTHER', 'description': 'The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)', 'armGroupLabels': ['laparoscopic Roux en Y Gastric Bypass', 'laparoscopic Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63069', 'city': 'Offenbach', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Sana Klinikum Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}], 'overallOfficials': [{'name': 'Christine Stier, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sana Klinikum Offenbach'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sana Klinikum Offenbach', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sonja Chiappetta, MD', 'investigatorAffiliation': 'Sana Klinikum Offenbach'}}}}