Comparative Effectiveness of Bariatric Surgery With PROMs (LOBSTER PROMs)
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ClinicalTrials.gov Identifier: NCT02749305 |
Recruitment Status :
Recruiting
First Posted : April 22, 2016
Last Update Posted : February 24, 2021
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Condition or disease | Intervention/treatment | Phase |
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Bariatric Surgery Metabolic Surgery Weight Reduction | Other: Collection of patient-reported outcome measures | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs) |
Study Start Date : | March 2016 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 31, 2022 |

Arm | Intervention/treatment |
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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.
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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. |
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.
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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. |
- Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10 [ Time Frame: preoperatively and annually postoperatively ]patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
- Patient-reported Obesity-related Problems [ Time Frame: preoperatively and annually postoperatively ]patients will be asked to complete the Obesity-related Problems Scale
- Patient-reported Obesity and Weight-loss Quality of Life [ Time Frame: preoperatively and annually postoperatively ]patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument
- Patient-reported comorbidities [ Time Frame: annually postoperatively ]patients will be asked to report their obesity-related comorbidities

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749305
Contact: Meridith Greene, PhD | 617 643 8761 | megreene@mgh.harvard.edu |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Meridith Greene, PhD 617-643-8761 megreene@mgh.harvard.edu |
Responsible Party: | Matthew Hutter, Medical Director of the Codman Center, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT02749305 |
Other Study ID Numbers: |
2016P000346 CER-1503-29209 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute ) |
First Posted: | April 22, 2016 Key Record Dates |
Last Update Posted: | February 24, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Weight Loss Body Weight Changes Body Weight |