Korean OBEsity Surgical Treatment Study
KOBESS
Efficacy and Safety of Bariatric Surgery for Korean Morbidly Obese Patients : Prospective Multicenter Cohort Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 4, 2017
March 1, 2017
1.2 years
February 23, 2017
April 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
body weight (cm) change
postoperative 1-year
waist circumference (cm) change
postoperative 1-year
Secondary Outcomes (7)
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
Morbidity
postoperative 1-year
Mortality
postoperative 1-month
Micronutrients' deficiency
postoperative 1-year
- +2 more secondary outcomes
Study Arms (1)
bariatric surgery
EXPERIMENTALThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Related Publications (2)
Lee G, Park YS, Cho C, Lee H, Park J, Park DJ, Lee JH, Lee HJ, Ha TK, Kim YJ, Ryu SW, Han SM, Yoo MW, Park S, Han SU, Heo Y, Jung BH. Short-term changes in the serum metabolome after laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. Metabolomics. 2021 Aug 5;17(8):71. doi: 10.1007/s11306-021-01826-y.
PMID: 34355282DERIVEDPark YS, Park DJ, Lee JH, Lee HJ, Ha TK, Kim YJ, Ryu SW, Han SM, Yoo MW, Park S, Han SU, Heo Y. Korean OBEsity Surgical Treatment Study (KOBESS): protocol of a prospective multicentre cohort study on obese patients undergoing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. BMJ Open. 2017 Oct 16;7(10):e018044. doi: 10.1136/bmjopen-2017-018044.
PMID: 29042391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2017
First Posted
April 4, 2017
Study Start
September 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
April 4, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share