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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03100292
Other study ID # B-1608/357-005
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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