Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs (NCT02749305) | Clinical Trial Compass
CompletedNot Applicable
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
United States11,146 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
0 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
Timeframe: preoperatively and annually postoperatively
2
Patient-reported Obesity-related Problems
Timeframe: preoperatively and annually postoperatively
3
Patient-reported Obesity and Weight-loss Quality of Life
Timeframe: preoperatively and annually postoperatively