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Obesity, MorbidNCT04040413

Database Maintenance for Bariatric Procedures

An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by Sheba Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Bariatric surgery registry for quality control and investigational purposes. Read more about this study

Who is it for?
Any age
Conditions the study is for
Obesity, Morbid, Bariatric Surgery Candidate
What is being tested?
bariatric surgery
Type of treatment
Surgery or procedure
How many people
5,000 participants
Where
1 siteIsrael
Study dates
1 Jan 2014to Dec 2026
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All morbidly obese individuals seeking bariatric surgery and approved by multidisciplinary bariatric committee.

Who may be able to join

  • morbid obesity

Who cannot join

  • unfit for surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel1 site, 1 recruiting

  • Sheba Medical Center

    Ramat Gan, 65261

    David Goitein, MD, 97235302714, david.goitein@sheba.health.gov.il

    Gal Levi, 97235307595, gal.levi@sheba.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: Institutional Bariatric Database Registry

Bariatric surgery registry for quality control and investigational purposes.

Being tested
bariatric surgery
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric surgeryProcedure or surgery

    All bariatric procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 10 years

  2. Percent total weight loss (%TWL)

    [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100

    Measured: 1 year from surgery

  3. Percent total weight loss (%TWL)

    [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100

    Measured: 5 years from surgery

  4. Percent total weight loss (%TWL)

    [(Weight at time of surgery - Weight at time point)/Weight at time of surgery]X100

    Measured: 10 years from surgery

  5. Percent BMI loss (%BMIL)

    [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100

    Measured: 1 year from surgery

  6. Percent BMI loss (%BMIL)

    [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100

    Measured: 5 years from surgery

  7. Percent BMI loss (%BMIL)

    [BMI at time of surgery - BMI at time point)/BMI at time of surgery] X 100

    Measured: 10 years from surgery

Secondary outcomes (5)

  1. 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.)

    Measured: 1 year from surgery

  2. 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.)

    Measured: 5 years from surgery

  3. 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.)

    Measured: 10 years from surgery

  4. 30 day morbidity/mortality

    30 day morbidity/mortality according to Clavien Dindo criteria

    Measured: up to 30 days from intervention

  5. long-term morbidity/mortality

    morbidity/mortality according to Clavien Dindo criteria after 30 days

    Measured: 31 days to 10 years from surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2019
  2. Study start1 Jan 2014
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04040413
Sponsor's protocol ID
SMC-14-1828
Status last verified
Apr 2024
First submitted
26 Jul 2019
Last updated
23 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by Sheba Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgery type (time frame: 10 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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Database Maintenance for Bariatric Procedures | AzTrials