Korean OBEsity Surgical Treatment Study (KOBESS)

April 3, 2017 updated by: Do Joong Park, Seoul National University Bundang Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Sang-Uk Han, M.D., Ph.D.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoon-Seok Heo, M.D., Ph.D.
        • Principal Investigator:
          • Hyuk-Joon Lee, M.D., Ph.D.
        • Principal Investigator:
          • Sang-Moon Han, M.D., Ph.D.
        • Principal Investigator:
          • Joo Ho Lee, M.D., Ph.D.
        • Principal Investigator:
          • Seung Wan Ryu, M.D., Ph.D.
        • Principal Investigator:
          • Moon-Won Yoo, M.D., Ph.D.
        • Principal Investigator:
          • Seung Ho Choi, M.D., Ph.D.
        • Principal Investigator:
          • Tae Kyung Ha, M.D., Ph.D.
        • Principal Investigator:
          • Sung-Soo Park, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bariatric surgery

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
body weight (cm) change
Time Frame: postoperative 1-year
postoperative 1-year
waist circumference (cm) change
Time Frame: postoperative 1-year
postoperative 1-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of Health & Welfare, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1608/357-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Morbid

Clinical Trials on Sleeve gastrectomy or Roux-en-Y gastric bypass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe