Bariatric Surgery Candidate, Obesity, Morbid
Conditions
Keywords
primary bariatric surgery, morbid obesity, South Korea, sleeve gastrectomy, Roux-en Y gastric bypass
Brief summary
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.
Interventions
OTHERSleeve gastrectomy or Roux-en-Y gastric bypass
Sponsors
Ministry of Health & Welfare, Korea
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight (cm) change | postoperative 1-year |
| waist circumference (cm) change | postoperative 1-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | postoperative 1-year | — |
| Mortality | postoperative 1-month | — |
| remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea) | postoperative 1-year | — |
| body composition change | postoperative 1-year | bioelectrical impedance analysis and fat measurement CT |
| cost-effectiveness | postoperative 1-year | cost-utility analysis using lifetime expected costs and quality-adjusted life years (QALYs) |
| Micronutrients' deficiency | postoperative 1-year | iron, ferritin, calcium, phosphate, albumin, vit.B12, vit.D, and parathyroid hormone |
| Quality of life change | postoperative 1-year | 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 |
Countries
South Korea
Contacts
Primary ContactYoung Suk Park, M.D.
Backup ContactDo Joong Park, M.D., Ph.D.
Outcome results
None listed