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Database Maintenance for Bariatric Procedures

Institutional Bariatric Database Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04040413
Enrollment
5000
Registered
2019-07-31
Start date
2014-01-01
Completion date
2026-12-31
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity, Morbid

Brief summary

Bariatric surgery registry for quality control and investigational purposes.

Interventions

PROCEDUREbariatric surgery

All bariatric procedures

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* morbid obesity

Exclusion criteria

* unfit for surgery

Design outcomes

Primary

MeasureTime frameDescription
Surgery type10 yearsSleeve 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)1 year from surgery\[(Weight at time of surgery - Weight at time point)/Weight at time of surgery\]X100
Percent BMI loss (%BMIL)1 year from surgery\[BMI at time of surgery - BMI at time point)/BMI at time of surgery\] X 100

Secondary

MeasureTime frameDescription
Co-morbidity resolution1 year from surgeryCessation of medication/s used to treat weight-related co-morbidities (i.e. diabetes mellitus type 2, hypertension, dyslipidemia, degenerative joint disease etc.)
30 day morbidity/mortalityup to 30 days from intervention30 day morbidity/mortality according to Clavien Dindo criteria
long-term morbidity/mortality31 days to 10 years from surgerymorbidity/mortality according to Clavien Dindo criteria after 30 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026