Five-year Outcome of Laparoscopic Gastric Sleeve

Metabolic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467581
• Other study ID #: Sleeve5years
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 9, 2018
• Start date: October 8, 2008
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2018
• Source: Tartu University Hospital
• Contact: Toomas Sillakivi, Dr, PhD
• Email: toomas.sillakivi[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgeries
• Metabolic Surgery

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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