Obesity Clinical Trial
— SGOfficial title:
A Decade of Sleeve Gastrectomy as a Single Bariatric/Metabolic Procedure: Analysis of Short and Long-term Outcome of 562 Patients
Verified date | October 2016 |
Source | Medical Park Gaziantep Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Observational |
Obesity is a chronic disease and its treatment requires close follow-up to accurately assess
the efficacy and durability of any treatment strategy. It is widely accepted that bariatric
surgery patients require lifetime follow-up to assess for weight loss, co-morbidity changes,
and nutritional deficiencies.
The study objective was to ascertain efficacy of weight loss and complication rates in 562
consecutive cases of laparoscopic sleeve gastrectomy (LSG) in a single surgeon practice.
Status | Completed |
Enrollment | 562 |
Est. completion date | June 2016 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - underwent LSG for morbid obesity and related morbidities as a primary procedure Exclusion Criteria: - previous history of obesity surgery |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical Park Gaziantep Hospital | Harran University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent excess body mass index loss (%EBMIL) | calculated using formula: %EBMIL = [?BMI / (initial BMI - 25)] x 100 | through study completion, an average of 1 year | No |
Secondary | Hemoglobin A1c (HbA1c) | Definitions of glycemic outcomes after sleeve gastrectomy | through study completion, an average of 1 year | No |
Secondary | change on lipid profile | Change on lipid profile before and after bariatric surgery was reported according to the Adult Treatment Panel III Guidelines, 2001, of the National Heart, Lung and Blood Institute as follows: no change, improvement in dislipidemia (defined as decrease in number or dose of lipid-lowering agents with equivalent control of dyslipidemia or improved control of lipids on equivalent medication) and remission (defined as normal lipid panel off medication). | through study completion, an average of 1 year | No |
Secondary | percent of complications | Complications were evaluated under two headings. Major complications were defined as any complication that resulted in a prolonged hospital stay (beyond 7 days), reintervention, or reoperation. Minor complications were included everything else that is not included under major. They were further categorized as early if observed in 30 days or late if beyond 30 days. | through study completion, an average of 1 year | No |
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