Korean OBEsity Surgical Treatment Study

Study Overview
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Brief Summary
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This trial is a multi-center, single-arm, prospective, observational cohort study of patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean follow-up period of 1 year after surgery. The eligible subjects who have given their consent to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y gastric bypass. The primary objective of this clinical trial is to measure the changes in body weight (kg) and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life. Additionally, postoperative incidences of morbidity and mortality, micronutrient status, body composition, and cost-effectiveness of surgical intervention will be examined.

Official Title
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Efficacy and Safety of Bariatric Surgery for Korean Morbidly Obese Patients : Prospective Multicenter Cohort Study

Conditions
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Bariatric Surgery Candidate, Obesity, Morbid

Intervention / Treatment
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* Other: Sleeve gastrectomy or Roux-en-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea being suitable for general anesthesia being able to give informed consent and committed to follow-up Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year. Exclusion Criteria: prior bariatric surgery of any kind being unable to understand the risks, benefits and compliance requirements of this trial pregnancy or planning on being pregnancy non-Korean speaker American society of anesthesiology (ASA) class IV or higher malignancy within 5 years.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bariatric surgery<br>This trial is a single-arm study and the enrolled patients are going to undergo sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB). If the patient has Barrett's esophagus on the preoperative endoscopy, SG is not permitted. Inflammatory bowel disease and Helicobacter pylori infection on a rapid urease test are contraindications of RYGB. | Other: Sleeve gastrectomy or Roux-en-Y gastric bypass<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight (cm) change |  | postoperative 1-year | 
| waist circumference (cm) change |  | postoperative 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea) |  | postoperative 1-year | 
| Quality of life change | EuroQol-5D (EQ-5D), the impact of weight on QoL (IWQOL) and the obesity-related psychosocial problem scale (OP-scale) are used to assess the improvement of QoL | postoperative 1-year | 
| Morbidity |  | postoperative 1-year | 
| Mortality |  | postoperative 1-month | 
| Micronutrients' deficiency | iron, ferritin, calcium, phosphate, albumin, vit.B12, vit.D, and parathyroid hormone | postoperative 1-year | 
| body composition change | bioelectrical impedance analysis and fat measurement CT | postoperative 1-year | 
| cost-effectiveness | cost-utility analysis using lifetime expected costs and quality-adjusted life years (QALYs) | postoperative 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary bariatric surgery, morbid obesity, South Korea, sleeve gastrectomy, Roux-en Y gastric bypass