Comparative Effectiveness of Bariatric Surgery With PROMs

Bariatric Surgery Clinical Trial

— LOBSTER PROMs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02749305
• Other study ID #: 2016P000346
• Secondary ID: CER-1503-29209
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Metabolic Surgery
• Weight Loss
• Weight Reduction

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