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OpenTrials
Completed

NCT Number: NCT02749305

Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs

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.

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Key information

Conditions

Bariatric Surgery Body Weight Body Weight Changes Metabolic Surgery Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss Weight Reduction

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of patient-reported outcome measures

Other

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.

Primary outcomes

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

    Time frame: preoperatively and annually postoperatively

    patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey

  2. Patient-reported Obesity-related Problems

    Time frame: preoperatively and annually postoperatively

    patients will be asked to complete the Obesity-related Problems Scale

  3. Patient-reported Obesity and Weight-loss Quality of Life

    Time frame: preoperatively and annually postoperatively

    patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument

  4. Patient-reported comorbidities

    Time frame: annually postoperatively

    patients will be asked to report their obesity-related comorbidities

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)

Acronym: MBSAQIP-PROM

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2016
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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