Five-year Outcome of Laparoscopic Gastric Sleeve

Recruiting

• Conditions: Bariatric Surgeries; Metabolic Surgery

• Registration Number: NCT03467581
• Lead Sponsor: Tartu University Hospital

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.

Study Timeline

• Study Start: 2008-10-08
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

• Patients who did not fill the inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Five-year outcome of laparoscopic gastric sleeve	5-year follow-up	5-year outcome in terms of weight loss, calculated in mean excess weight lost (%EWL).

Secondary Outcome Measures

Name	Time	Method
Five-year outcome of laparoscopic gastric sleeve	5-year follow-up	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.

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia