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Clinical Trials/NCT04040413
NCT04040413
Recruiting
Not Applicable

Institutional Bariatric Database Registry

Sheba Medical Center1 site in 1 country5,000 target enrollmentJanuary 1, 2014
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ConditionsObesity, MorbidBariatric Surgery Candidate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Morbid
Sponsor
Sheba Medical Center
Enrollment
5000
Locations
1
Primary Endpoint
Surgery type
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Bariatric surgery registry for quality control and investigational purposes.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Goitein MD

Head, Bariatric and Metabolic Surgery

Sheba Medical Center

Eligibility Criteria

Inclusion Criteria

  • •morbid obesity

Exclusion Criteria

  • •unfit for surgery

Outcomes

Primary Outcomes

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)

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

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

Secondary Outcomes

  • Co-morbidity resolution(10 years from surgery)
  • 30 day morbidity/mortality(up to 30 days from intervention)
  • long-term morbidity/mortality(31 days to 10 years from surgery)

Study Sites (1)

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