Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 12:12 PM
Study NCT ID:
NCT02749305
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2016-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10', 'timeFrame': 'preoperatively and annually postoperatively', 'description': 'patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey'}, {'measure': 'Patient-reported Obesity-related Problems', 'timeFrame': 'preoperatively and annually postoperatively', 'description': 'patients will be asked to complete the Obesity-related Problems Scale'}, {'measure': 'Patient-reported Obesity and Weight-loss Quality of Life', 'timeFrame': 'preoperatively and annually postoperatively', 'description': 'patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument'}, {'measure': 'Patient-reported comorbidities', 'timeFrame': 'annually postoperatively', 'description': 'patients will be asked to report their obesity-related comorbidities'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery', 'Metabolic Surgery', 'Weight Reduction']}, 'referencesModule': {'references': [{'pmid': '37949691', 'type': 'BACKGROUND', 'citation': 'Greene ME, Grieco A, Evans-Labok K, Ko CY, Hutter MM. First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2024 Feb;20(2):173-183. doi: 10.1016/j.soard.2023.09.010. Epub 2023 Sep 15.'}, {'pmid': '37037688', 'type': 'BACKGROUND', 'citation': 'Greene ME, Goldman RE, Hutter MM. Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2023 Aug;19(8):897-906. doi: 10.1016/j.soard.2023.01.031. Epub 2023 Feb 9.'}, {'pmid': '36400692', 'type': 'BACKGROUND', 'citation': 'Grieco A, Greene ME, Ko CY, Cohen ME, Evans-Labok K, Fraker T, Hutter MM. Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery. Surg Obes Relat Dis. 2023 Apr;19(4):309-317. doi: 10.1016/j.soard.2022.10.001. Epub 2022 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion.\n\nPostoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center.\n\nExclusion Criteria Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center.\n\nPostoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.'}, 'identificationModule': {'nctId': 'NCT02749305', 'acronym': 'MBSAQIP-PROM', 'briefTitle': 'Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)', 'orgStudyIdInfo': {'id': '2016P000346'}, 'secondaryIdInfos': [{'id': 'CER-1503-29209', 'type': 'OTHER_GRANT', 'domain': 'Patient Centered Outcomes Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Preop Metabolic & Bariatric Patients', 'description': 'Attempted collection of patient-reported outcome measures preoperatively and annually postoperatively will occur with all metabolic and bariatric surgery patients scheduled for surgery at a participating center.', 'interventionNames': ['Other: Collection of patient-reported outcome measures']}, {'type': 'OTHER', 'label': 'Postop Metabolic & Bariatric Patients', 'description': 'Attempted collection of patient-reported outcome measures annually postoperatively will occur with all metabolic and bariatric surgery patients who had surgery at a participating center within the preceding 12 months.', 'interventionNames': ['Other: Collection of patient-reported outcome measures']}], 'interventions': [{'name': 'Collection of patient-reported outcome measures', 'type': 'OTHER', 'description': 'Preoperative and postoperative metabolic and bariatric surgery patients will be asked to electronically complete a set of PROMs up to 21 days before surgery and annually on their surgical anniversary they will be asked to complete a postoperative PROM.', 'armGroupLabels': ['Postop Metabolic & Bariatric Patients', 'Preop Metabolic & Bariatric Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director of the Codman Center', 'investigatorFullName': 'Matthew Hutter', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}