Korean OBEsity Surgical Treatment Study
Korean OBEsity Surgical Treatment Study
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.
Inclusion Criteria:

 1. body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as
 hypertension, glucose intolerance, dyslipidemia, and sleep apnea

 2. being suitable for general anesthesia

 3. being able to give informed consent and committed to follow-up

 4. Female patients should have a negative urine pregnancy test at screening and agree to
 use reliable method of contraception for 1 year.

 Exclusion Criteria:

 1. prior bariatric surgery of any kind

 2. being unable to understand the risks, benefits and compliance requirements of this
 trial

 3. pregnancy or planning on being pregnancy

 4. non-Korean speaker

 5. American society of anesthesiology (ASA) class IV or higher

 6. malignancy within 5 years.