NCT04663425

Brief Summary

Patients that underwent any type of bariatric surgery with BMI more than 60 will recruited for follow up that includes: actual weight, other surgeries and conversions, co-morbidities status, medications and satisfaction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

April 4, 2008

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

December 11, 2020

Status Verified

October 1, 2020

Enrollment Period

11.4 years

First QC Date

October 16, 2020

Last Update Submit

December 6, 2020

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

  • Weight loss after bariatric surgery

    change in bodyweight following the surgery (kg)

    from 1 to 12 years

  • co-morbidities rate following surgery

    prevalence of diseases linked to obesity (hypertension, diabetes, sleep apnea)

    from 1 to 12 years

Study Arms (3)

Sleeve gastrectomy operation

Outcome of patients that underwent sleeve gastrectomy with BMI greater than 60.

Gastric bypass operation

Outcome of patients that underwent gastric bypass with BMI greater than 60.

Gastric Band operation

Outcome of patients that underwent gastric banding with BMI greater than 60.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients accepted to underwent bariatric surgery with BMI equal or above 60

You may qualify if:

  • BMI above 60 Any bariatric surgery performed including revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of General Surgery Department

Study Record Dates

First Submitted

October 16, 2020

First Posted

December 11, 2020

Study Start

April 4, 2008

Primary Completion

August 19, 2019

Study Completion

September 30, 2020

Last Updated

December 11, 2020

Record last verified: 2020-10