Database Maintenance for Bariatric Procedures

Bariatric Surgery Candidate Clinical Trial

Official title:

Institutional Bariatric Database Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040413
• Other study ID #: SMC-14-1828
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Bariatric surgery registry for quality control and investigational purposes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• morbid obesity

Exclusion Criteria:

• unfit for surgery

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid

Intervention

Procedure:
• bariatric surgery
All bariatric procedures

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery type	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
Primary	Percent total weight loss (%TWL)	[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100	1 year from surgery
Primary	Percent total weight loss (%TWL)	[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100	5 years from surgery
Primary	Percent total weight loss (%TWL)	[(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100	10 years from surgery
Primary	Percent BMI loss (%BMIL)	[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100	1 year from surgery
Primary	Percent BMI loss (%BMIL)	[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100	5 years from surgery
Primary	Percent BMI loss (%BMIL)	[BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100	10 years from surgery
Secondary	Co-morbidity resolution	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
Secondary	Co-morbidity resolution	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
Secondary	Co-morbidity resolution	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
Secondary	30 day morbidity/mortality	30 day morbidity/mortality according to Clavien Dindo criteria	up to 30 days from intervention
Secondary	long-term morbidity/mortality	morbidity/mortality according to Clavien Dindo criteria after 30 days	31 days to 10 years from surgery