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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 0 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Meridith Greene, PhD
617-643-8761
megreene@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.