NCT04040413

Brief Summary

Bariatric surgery registry for quality control and investigational purposes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2014Dec 2026

Study Start

First participant enrolled

January 1, 2014

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

12.9 years

First QC Date

July 26, 2019

Last Update Submit

April 21, 2024

Conditions

Obesity, MorbidBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (7)

  • 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

  • Percent total weight loss (%TWL)

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

    1 year from surgery

  • Percent total weight loss (%TWL)

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

    5 years from surgery

  • Percent total weight loss (%TWL)

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

    10 years from surgery

  • Percent BMI loss (%BMIL)

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

    1 year from surgery

  • Percent BMI loss (%BMIL)

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

    5 years from surgery

  • 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 Outcomes (5)

  • Co-morbidity resolution

    1 year from surgery

  • Co-morbidity resolution

    5 years from surgery

  • Co-morbidity resolution

    10 years from surgery

  • 30 day morbidity/mortality

    up to 30 days from intervention

  • long-term morbidity/mortality

    31 days to 10 years from surgery

Interventions

bariatric surgeryPROCEDURE

All bariatric procedures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • morbid obesity

You may not qualify if:

  • unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 65261, Israel

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Bariatric and Metabolic Surgery

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 31, 2019

Study Start

January 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)