Korean OBEsity Surgical Treatment Study

Not Applicable

• Conditions: Bariatric Surgery Candidate; Obesity, Morbid
• Interventions: Other: Sleeve gastrectomy or Roux-en-Y gastric bypass

• Registration Number: NCT03100292
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-02-23
• Status Verified: 2017-03
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-04
• Last Update Posted: 2017-04-04
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bariatric surgery	Sleeve gastrectomy or Roux-en-Y gastric bypass	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.

Primary Outcome Measures

Name	Time	Method
body weight (cm) change	postoperative 1-year
waist circumference (cm) change	postoperative 1-year

Secondary Outcome Measures

Name	Time	Method
body composition change	postoperative 1-year	bioelectrical impedance analysis and fat measurement CT
remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea)	postoperative 1-year
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
Morbidity	postoperative 1-year
Mortality	postoperative 1-month
Micronutrients' deficiency	postoperative 1-year	iron, ferritin, calcium, phosphate, albumin, vit.B12, vit.D, and parathyroid hormone
cost-effectiveness	postoperative 1-year	cost-utility analysis using lifetime expected costs and quality-adjusted life years (QALYs)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of