Bariatric SurgeryMBSAQIP-PROMNCT02749305
Comparative Effectiveness of Metabolic and Bariatric Surgery With PROMs
A study testing Collection of patient-reported outcome measures in people with Bariatric Surgery and Metabolic Surgery, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Bariatric Surgery, Metabolic Surgery, Weight Reduction
- What is being tested?
- Collection of patient-reported outcome measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,146 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)
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
- Bariatric Surgery, Metabolic Surgery, Weight Reduction
- Being tested
- Collection of patient-reported outcome measures
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of patient-reported outcome measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preop Metabolic & Bariatric Patients | Other | 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. Receives: Other: Collection of patient-reported outcome measures |
| Postop Metabolic & Bariatric Patients | Other | 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. Receives: Other: Collection of patient-reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
Measured: preoperatively and annually postoperatively
Patient-reported Obesity-related Problems
patients will be asked to complete the Obesity-related Problems Scale
Measured: preoperatively and annually postoperatively
Patient-reported Obesity and Weight-loss Quality of Life
patients will be asked to complete the Obesity and Weight-loss Quality of Life instrument
Measured: preoperatively and annually postoperatively
Patient-reported comorbidities
patients will be asked to report their obesity-related comorbidities
Measured: annually postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Hutter, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749305
- Sponsor's protocol ID
- 2016P000346
- Other IDs
- CER-1503-29209
- Acronym
- MBSAQIP-PROM
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2016
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Greene ME, Grieco A, Evans-Labok K, Ko CY, Hutter MM. First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2024 Feb;20(2):173-183. doi: 10.1016/j.soard.2023.09.010. Epub 2023 Sep 15.
PubMed 37949691Greene ME, Goldman RE, Hutter MM. Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2023 Aug;19(8):897-906. doi: 10.1016/j.soard.2023.01.031. Epub 2023 Feb 9.
PubMed 37037688Grieco A, Greene ME, Ko CY, Cohen ME, Evans-Labok K, Fraker T, Hutter MM. Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery. Surg Obes Relat Dis. 2023 Apr;19(4):309-317. doi: 10.1016/j.soard.2022.10.001. Epub 2022 Oct 11.
PubMed 36400692
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Metabolic and Bariatric Surgical Procedures Using Patient Reported Outcome Measures (PROMs)
- ClinicalTrials.gov ID
- NCT02749305
- Acronym / sponsor ID
- MBSAQIP-PROM / 2016P000346
- Conditions
- Bariatric Surgery, Metabolic Surgery, Weight Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,146 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preop Metabolic & Bariatric Patients | Other | Other: Collection of patient-reported outcome measuresAttempted 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. |
| Postop Metabolic & Bariatric Patients | Other | Other: Collection of patient-reported outcome measuresAttempted 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of patient-reported outcome measuresPreoperative 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, Preop Metabolic & Bariatric Patients |
Primary outcome
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10
Time frame: preoperatively and annually postoperatively
patients will be asked to complete the PROMIS (Patient-Reported Outcomes Measurement Information System) 10 survey
Patient-reported Obesity-related Problems
Time frame: preoperatively and annually postoperatively
patients will be asked to complete the Obesity-related Problems Scale
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
Patient-reported comorbidities
Time frame: annually postoperatively
patients will be asked to report their obesity-related comorbidities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Background: PubMed 37949691Greene ME, Grieco A, Evans-Labok K, Ko CY, Hutter MM. First report of outcomes from the patient-reported outcome measures program in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2024 Feb;20(2):173-183. doi: 10.1016/j.soard.2023.09.010. Epub 2023 Sep 15.
- Background: PubMed 37037688Greene ME, Goldman RE, Hutter MM. Selection of patient-reported outcomes measures for implementation in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program. Surg Obes Relat Dis. 2023 Aug;19(8):897-906. doi: 10.1016/j.soard.2023.01.031. Epub 2023 Feb 9.
- Background: PubMed 36400692Grieco A, Greene ME, Ko CY, Cohen ME, Evans-Labok K, Fraker T, Hutter MM. Evaluating agreement between clinic- and patient-reported outcomes for weight and co-morbidities at 1 year after bariatric surgery. Surg Obes Relat Dis. 2023 Apr;19(4):309-317. doi: 10.1016/j.soard.2022.10.001. Epub 2022 Oct 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of patient-reported outcome measures in people with Bariatric Surgery and Metabolic Surgery, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported PROMIS (Patient-Reported Outcomes Measurement Information System) 10 (time frame: preoperatively and annually postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02749305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.