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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02749305
Other study ID # 2016P000346
Secondary ID CER-1503-29209
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date October 31, 2022

Study information

Verified date May 2022
Source Massachusetts General Hospital
Contact Meridith Greene, PhD
Phone 617 643 8761
Email megreene@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200000
Est. completion date October 31, 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Other:
Collection 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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

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