CompletedNot Applicable

Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs

United States11,146 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range0 Years

SexALL

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Inclusion Criteria All preoperative metabolic and bariatric surgery patients with a scheduled metabolic and bariatric surgery at a participating center are eligible for inclusion. Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center. Exclusion Criteria Metabolic and bariatric surgery patients without an already scheduled surgery date at a participating center. Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.

What they're measuring

Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10

Timeframe: preoperatively and annually postoperatively

Patient-reported Obesity-related Problems

Timeframe: preoperatively and annually postoperatively

Patient-reported Obesity and Weight-loss Quality of Life

Timeframe: preoperatively and annually postoperatively

Patient-reported comorbidities

Timeframe: annually postoperatively

Trial details

NCT IDNCT02749305

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02

View on ClinicalTrials.gov More Bariatric Surgery trials