NCT02749305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

7.9 years

First QC Date

March 25, 2016

Last Update Submit

April 16, 2025

Conditions

Bariatric SurgeryMetabolic SurgeryWeight Reduction

Outcome Measures

Primary Outcomes (4)

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

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

    preoperatively and annually postoperatively

  • Patient-reported Obesity-related Problems

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

    preoperatively and annually postoperatively

  • Patient-reported Obesity and Weight-loss Quality of Life

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

    preoperatively and annually postoperatively

  • Patient-reported comorbidities

    patients will be asked to report their obesity-related comorbidities

    annually postoperatively

Study Arms (2)

Preop Metabolic & Bariatric Patients

OTHER

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.

Other: Collection of patient-reported outcome measures

Postop Metabolic & Bariatric Patients

OTHER

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.

Other: Collection of patient-reported outcome measures

Interventions

Collection of patient-reported outcome measuresOTHER

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.

Postop Metabolic & Bariatric PatientsPreop Metabolic & Bariatric Patients

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postoperative metabolic and bariatric surgery patients must have had their surgery within the preceding year at a participating center.

You may not qualify if:

  • Postoperative metabolic and bariatric surgery patients who are more than 1 year postop from a participating center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • 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: 37949691BACKGROUND

  • 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: 37037688BACKGROUND

  • 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.

    PMID: 36400692BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of the Codman Center

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 22, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

April 20, 2025

Record last verified: 2025-04

Locations

US(1)