Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs

Not Applicable

Completed

• Conditions: Bariatric Surgery; Weight Reduction; Metabolic Surgery
• Interventions: Other: Collection of patient-reported outcome measures

• Registration Number: NCT02749305
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Primary Completion: 2024-02
• Study Completion: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postop Metabolic & Bariatric Patients	Collection of patient-reported outcome measures	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.
Preop Metabolic & Bariatric Patients	Collection of patient-reported outcome measures	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.

Primary Outcome Measures

Name	Time	Method
Patient-reported comorbidities	annually postoperatively	patients will be asked to report their obesity-related comorbidities
Patient-reported Obesity-related Problems	preoperatively and annually postoperatively	patients will be asked to complete the Obesity-related Problems Scale
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10	preoperatively and annually postoperatively	patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
Patient-reported Obesity and Weight-loss Quality of Life	preoperatively and annually postoperatively	patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States