Database Maintenance for Bariatric Procedures

April 21, 2024 updated by: David Goitein MD, Sheba Medical Center

Institutional Bariatric Database Registry

Bariatric surgery registry for quality control and investigational purposes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All morbidly obese individuals seeking bariatric surgery and approved by multidisciplinary bariatric committee.

Description

Inclusion Criteria:

  • morbid obesity

Exclusion Criteria:

  • unfit for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery type
Time Frame: 10 years
Sleeve gastrectomy or Roux-Y gastric bypass (RYGBP) or Single anastomosis gastric bypass (SAGB) or biliopancreatic diversion (BPD/DS) or single anastomosis duodeno-ilial bypass (SADI)
10 years
Percent total weight loss (%TWL)
Time Frame: 1 year from surgery
[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100
1 year from surgery
Percent total weight loss (%TWL)
Time Frame: 5 years from surgery
[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100
5 years from surgery
Percent total weight loss (%TWL)
Time Frame: 10 years from surgery
[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100
10 years from surgery
Percent BMI loss (%BMIL)
Time Frame: 1 year from surgery
[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100
1 year from surgery
Percent BMI loss (%BMIL)
Time Frame: 5 years from surgery
[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100
5 years from surgery
Percent BMI loss (%BMIL)
Time Frame: 10 years from surgery
[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100
10 years from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-morbidity resolution
Time Frame: 1 year from surgery
Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.)
1 year from surgery
Co-morbidity resolution
Time Frame: 5 years from surgery
Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.)
5 years from surgery
Co-morbidity resolution
Time Frame: 10 years from surgery
Cessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.)
10 years from surgery
30 day morbidity/mortality
Time Frame: up to 30 days from intervention
30 day morbidity/mortality according to Clavien Dindo criteria
up to 30 days from intervention
long-term morbidity/mortality
Time Frame: 31 days to 10 years from surgery
morbidity/mortality according to Clavien Dindo criteria after 30 days
31 days to 10 years from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Estimated)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-14-1828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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