Comparative Effectiveness of Bariatric Surgery With PROMs (LOBSTER PROMs)

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

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery; Weight Reduction; Metabolic Surgery
• Intervention / Treatment: Other: Collection of patient-reported outcome measures

• Study Type: Interventional
• Enrollment (Anticipated): 200000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meridith Greene, PhD; Phone Number: 617 643 8761; Email: megreene@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Meridith Greene, PhD; Phone Number: 617-643-8761; Email: megreene@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preop Metabolic & Bariatric Patients; 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; 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.
Other: Postop Metabolic & Bariatric Patients; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2016P000346; CER-1503-29209 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided