Database Maintenance for Bariatric Procedures

Recruiting

• Conditions: Obesity, Morbid; Bariatric Surgery Candidate

• Registration Number: NCT04040413
• Lead Sponsor: Sheba Medical Center

Brief Summary

Bariatric surgery registry for quality control and investigational purposes.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• morbid obesity

Exclusion Criteria

• unfit for surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgery type	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)	10 years from surgery	\[(Weight at time of surgery - Weight at time point)/Weight at time of surgery\]X100
Percent BMI loss (%BMIL)	10 years from surgery	\[BMI at time of surgery - BMI at time point)/BMI at time of surgery\] X 100

Secondary Outcome Measures

Name	Time	Method
30 day morbidity/mortality	up to 30 days from intervention	30 day morbidity/mortality according to Clavien Dindo criteria
long-term morbidity/mortality	31 days to 10 years from surgery	morbidity/mortality according to Clavien Dindo criteria after 30 days
Co-morbidity resolution	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.)

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel