Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT03419104
Status:
UNKNOWN
Last Update Posted:
2018-03-13
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation', 'timeFrame': 'one hour postoperative', 'description': 'Number of participants with successful extubation and patients who does not need mechanical ventilation support'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'extubation'], 'conditions': ['Morbid Obesity', 'Weaning Failure']}, 'referencesModule': {'references': [{'pmid': '21719358', 'type': 'RESULT', 'citation': 'Gupta PK, Gupta H, Kaushik M, Fang X, Miller WJ, Morrow LE, Armour-Forse R. Predictors of pulmonary complications after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):574-81. doi: 10.1016/j.soard.2011.04.227. Epub 2011 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the efficacy of "60 meters 60 seconds exercise test" (a test designed by the study group) done preoperatively as a predictor test for postoperative intensive care unit need and extubation success in patients undergoing bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients between 18-60 years old patients with BMI \\> 40 patients undergoing Laparoscopic Sleeve Gastrectomy\n\nExclusion Criteria:\n\npatients with Chronic obstructive pulmonary disease (COPD) or Asthma, patients with uncompensated heart failure Patients Who have orthopedic problems that effects the exercise test (such as gonarthrosis)'}, 'identificationModule': {'nctId': 'NCT03419104', 'briefTitle': 'Preoperative Exercise Test and Postoperative Intensive Care Unit Need in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Use of Preoperative Exercise Test as Predictor for Postoperative Intensive Care Unit Need in Patients Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': 'IstanbulU ctf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative walk test', 'description': 'Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.', 'interventionNames': ['Diagnostic Test: preoperative walk test']}], 'interventions': [{'name': 'preoperative walk test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.', 'armGroupLabels': ['Preoperative walk test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'emre erbabacan, asc prof', 'role': 'CONTACT', 'email': 'emreerbabacan@gmail.com', 'phone': '5322067777'}], 'facility': 'Istanbul University Cerrahpasa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'emre erbabacan, asc prof', 'role': 'CONTACT', 'email': 'emreerbabacan@gmail.com', 'phone': '5322067777'}, {'name': 'cigdem akyol, MD', 'role': 'CONTACT', 'email': 'akyolbeyoglu@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr', 'investigatorFullName': 'Guniz M.Koksal', 'investigatorAffiliation': 'Istanbul University'}}}}