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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 : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Matthew Hutter, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Metabolic Surgery Weight Reduction Other: Collection of patient-reported outcome measures Not Applicable

Study Design
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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 : June 2019
Estimated Study Completion Date : October 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
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
Pre- and posto-perative 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.
 Other: Collection of patient-reported outcome measures
Pre- and posto-perative 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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient-reported PROMIS 10 [ Time Frame: preoperatively and annually postoperatively ]
    patients will be asked to complete the PROMIS 10 survey

  2. Patient-reported Obesity-related Problems [ Time Frame: preoperatively and annually postoperatively ]
    patients will be asked to complete the Obesity-related Problems Scale

  3. 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

  4. Patient-reported comorbidities [ Time Frame: annually postoperatively ]
    patients will be asked to report their obesity-related comorbidities


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria All preoperative metabolic and bariartic 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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Meridith Greene, PhD 617 643 8761 megreene@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Meridith Greene, PhD    617-643-8761    megreene@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Responsible Party: Matthew Hutter, Medical Director of the Codman Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02749305     History of Changes
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: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms