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| Comparative effectiveness of metabolic and bariatric surgery using patient-reported outcome measures (PROMs) | |
|---|---|
| Investigator (PI): | Hutter, Matthew |
| Performing Organization (PO): |
(Current): Massachusetts General Hospital, Corrigan Minehan Heart Center / (866) 644-8910 |
| Supporting Agency (SA): | Patient-Centered Outcomes Research Institute (PCORI) |
| Initial Year: | 2015 |
| Final Year: | 2023 |
| Record Source/Award ID: | PCORI/CER-1503-29209 |
| Funding: | Total Award Amount: $2,655,073 |
| Award Type: | Contract |
| Award Information: | PCORI: More information and project results (when completed) |
| Abstract: | Background and significance: Morbid obesity and obesity-related diseases are chronic conditions that affect more than 20 million people--a figure greater than the number of people living in the state of New York. Weight-loss surgery, or metabolic and bariatric surgery, has been shown to be an effective treatment. Outcomes from surgery currently focus on complications and weight loss, but do not include the type of information that patients care most about, like, "One year later, how much better off will I be?" Currently, there are three surgical procedures that have been shown to be effective for the treatment of obesity and obesity-related diseases: laparoscopic roux-en-y gastric bypass (bypass), laparoscopic sleeve gastrectomy (sleeve), and laparoscopic adjustable gastric band (band). Each procedure has different risks and benefits. A patient, with the help from his or her doctor, must decide which operation is best for his or her particular situation. When a physician can explain how much better off their patients will be one year after their operations, patients can best decide which operation is appropriate. Study description: In this study, researchers will work with patient focus groups to develop an electronic survey tool that measures the issues that patients care most about one year after weight-loss surgery--for example, their quality of life. Patients report how well they are doing--patient-reported outcome measures (PROMs). Across the country, all hospitals that are accredited to do weight-loss surgery will collect these PROMs. More than 89 percent of all weight-loss operations in the United States are currently being performed at hospitals accredited by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement (MBSAQIP). Approximately 13,000 patients a month have weight-loss surgery at one of these accredited centers, and some data are already being collected on all of them. Analysis: The patient-reported data will be combined with the MBSAQIP data and analyzed with advanced modeling techniques. Results will be used to compare the three most common weight-loss operations: the gastric bypass, the adjustable gastric band, or the sleeve gastrectomy. Data will be provided to patients on the web. Patients can enter their weight, age, and medical problems, and the computer will provide data to help these patients, or their doctors, decide which operation would be best for them and what the expected results are. Most importantly, this new data will measure the things that patients care most about and help them decide which weight-loss operation is best for their specific needs. |
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| Country: | United States |
| State: | Massachusetts |
| Zip Code: | 02114 |
| UI: | 20162116 |
| CTgovId: | NCT02749305 |
| Project Status: | Ongoing |
| Record History: | ('2020: Project extended to 2023. 2018: Project extended to 2021.',) |