Five-year Outcome of Laparoscopic Gastric Sleeve

Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Surgery; Bariatric Surgeries

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Toomas Sillakivi, Dr, PhD; Email: toomas.sillakivi@kliinikum.ee

Study Locations

• Estonia
  • Tartu, Estonia, 50406
    • Recruiting
    • Tartu University Hospital
    • Contact: Eva-Maria Kikkas, Dr; Phone Number: +37258162720; Email: evamariakikkas@gmail.com
    • Contact: Toomas Sillakivi, Dr, PhD; Email: toomas.sillakivi@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Five-year outcome of laparoscopic gastric sleeve	5-year risk for cumulative nutritional deficiencies. According to blood analysis results and patient provided information about taking supplementations (eg vitamine B12 or iron), prevalence of nutritional deficiencies are calculated in percetanges. Backward stepwise logistic regression is used to evaluate the risk factors for nutrition.	5-year follow-up

Collaborators and Investigators

• Sponsor: Tartu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2008
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: gastric sleeve
• Other Study ID Numbers: Sleeve5years

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No