Comparative Effectiveness of Bariatric Surgery With PROMs (LOBSTER PROMs)

Mass General Brigham

Status: Enrolling

Conditions: Weight Reduction; Metabolic Surgery; Bariatric Surgery

Treatments: Other: Collection of patient-reported outcome measures

Study type: Interventional

Funder types: Other

Identifiers

NCT02749305

2016P000346

CER-1503-29209 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 200,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200,000 participants in 2 patient groups

Preop Metabolic & Bariatric Patients

Other group

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.

Treatment:

Other: Collection of patient-reported outcome measures

Postop Metabolic & Bariatric Patients

Other group

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.

Treatment:

Other: Collection of patient-reported outcome measures