Korean OBEsity Surgical Treatment Study

Bariatric Surgery Candidate Clinical Trial

— KOBESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100292
• Other study ID #: B-1608/357-005
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: April 3, 2017
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Seoul National University Bundang Hospital
• Contact: Young Suk Park, M.D.
• Phone: +82-31-787-7099
• Email: selteenzeus[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid

Intervention

Other:
• Sleeve gastrectomy or Roux-en-Y gastric bypass

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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