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Recruiting

NCT Number: NCT04040413

Database Maintenance for Bariatric Procedures

Bariatric surgery registry for quality control and investigational purposes.

Recruiting

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • morbid obesity

Exclusion criteria

  • unfit for surgery

Treatment and study plan

bariatric surgery

Procedure

All bariatric procedures

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. 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.)

  2. 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.)

  3. 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.)

  4. 30 day morbidity/mortality

    Time frame: up to 30 days from intervention

    30 day morbidity/mortality according to Clavien Dindo criteria

  5. long-term morbidity/mortality

    Time frame: 31 days to 10 years from surgery

    morbidity/mortality according to Clavien Dindo criteria after 30 days

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Institutional Bariatric Database Registry

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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