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Comparative Effectiveness of Bariatric Surgery With PROMs (LOBSTER PROMs)

Primary Purpose

Bariatric Surgery, Metabolic Surgery, Weight Reduction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collection of patient-reported outcome measures
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Preop Metabolic & Bariatric Patients

Postop Metabolic & Bariatric Patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Patient-reported Obesity-related Problems
patients will be asked to complete the Obesity-related Problems Scale
Patient-reported Obesity and Weight-loss Quality of Life
patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument
Patient-reported comorbidities
patients will be asked to report their obesity-related comorbidities

Secondary Outcome Measures

Full Information

First Posted
March 25, 2016
Last Updated
May 17, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02749305
Brief Title
Comparative Effectiveness of Bariatric Surgery With PROMs
Acronym
LOBSTER PROMs
Official Title
Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Metabolic Surgery, Weight Reduction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preop Metabolic & Bariatric Patients
Arm Type
Other
Arm Description
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.
Arm Title
Postop Metabolic & Bariatric Patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collection of patient-reported outcome measures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
Description
patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
Time Frame
preoperatively and annually postoperatively
Title
Patient-reported Obesity-related Problems
Description
patients will be asked to complete the Obesity-related Problems Scale
Time Frame
preoperatively and annually postoperatively
Title
Patient-reported Obesity and Weight-loss Quality of Life
Description
patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument
Time Frame
preoperatively and annually postoperatively
Title
Patient-reported comorbidities
Description
patients will be asked to report their obesity-related comorbidities
Time Frame
annually postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meridith Greene, PhD
Phone
617 643 8761
Email
megreene@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meridith Greene, PhD
Phone
617-643-8761
Email
megreene@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparative Effectiveness of Bariatric Surgery With PROMs

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