NCT03467581

Brief Summary

The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Oct 2008

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 Progress87%
Oct 2008Dec 2028

Study Start

First participant enrolled

October 8, 2008

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

20.2 years

First QC Date

March 5, 2018

Last Update Submit

March 9, 2018

Conditions

Bariatric SurgeriesMetabolic Surgery

Keywords

gastric sleeve

Outcome Measures

Primary Outcomes (1)

  • Five-year outcome of laparoscopic gastric sleeve

    5-year outcome in terms of weight loss, calculated in mean excess weight lost (%EWL).

    5-year follow-up

Secondary Outcomes (2)

  • Five-year outcome of laparoscopic gastric sleeve

    5-year follow-up

  • Five-year outcome of laparoscopic gastric sleeve

    5-year follow-up

Eligibility Criteria

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

Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.

You may qualify if:

  • The criteria for bariatric surgery: BMI of \>40, or \>35 with certain obesity related comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Central Study Contacts

Toomas Sillakivi, Dr, PhD

CONTACT

toomas.sillakivi@kliinikum.ee

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical resident

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 16, 2018

Study Start

October 8, 2008

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

March 16, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)