Five-year Outcome of Laparoscopic Gastric Sleeve | NCT03467581

Studies
Five-year Outcome of Laparoscopic Gastric Sleeve

NCT03467581

Sponsor

Tartu University Hospital

Status

Recruiting

Last Update Posted

Mar 16, 2018Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Bariatric Surgeries
Metabolic Surgery

Interventions

Not provided

Countries

Estonia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2008Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Mar 5, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2018

Last Update Posted Date

Mar 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The consecutive patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital are followed prospectively in cohort study. The outpatient hospital follow-up visits are conducted at 3 months, 1 year and 5 years postoperatively.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Five-year outcome of laparoscopic gastric sleeve	5-year outcome of resolution of obesity-related comorbidities (type 2 diabetes mellitus, hypertension, obstructive sleep apnea, dyslipidemia). Prevalence of comorbidities are presented in percentages. McNemar´s test is employed to analyse significance of resolution of comorbidities.	5-year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who did not fill the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Toomas Sillakivi, Dr, PhD	Contact			toomas.sillakivi@kliinikum.ee

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tartu University Hospital	Recruiting	Tartu		50406	Estonia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided