Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02749305

Acronym

MBSAQIP-PROM

Enrollment

11146

Registered

2016-04-22

Start date

2016-03-31

Completion date

2024-02-01

Last updated

2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Metabolic Surgery, Weight Reduction

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.

Interventions

OTHERCollection of patient-reported outcome measures

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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-related Problems	preoperatively and annually postoperatively	patients will be asked to complete the Obesity-related Problems Scale
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
Patient-reported comorbidities	annually postoperatively	patients will be asked to report their obesity-related comorbidities

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026