Five-year Outcome of Laparoscopic Gastric Sleeve
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTartu University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The criteria for bariatric surgery: BMI of >40, or >35 with certain obesity related comorbidities
Disqualifiers
Patients who did not fill the inclusion criteria
Trial population
Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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).
Time frame
5-year follow-upSecondary outcomes
1
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.
Time frame
5-year follow-up2
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.
Time frame
5-year follow-upSponsors and contacts
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Source ClinicalTrials.gov