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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bariatric surgery | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy or Roux-en-Y gastric bypass | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight (cm) change | postoperative 1-year | |
| waist circumference (cm) change | postoperative 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea) | postoperative 1-year | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Suk Park, M.D. | Contact | +82-31-787-7099 | selteenzeus@gmail.com | |
| Do Joong Park, M.D., Ph.D. | Contact | +82-31-787-7099 | dojoongpark@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34355282 | Derived | 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. | |
| 29042391 | Derived |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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| postoperative 1-year |
| Morbidity | postoperative 1-year |
| Mortality | postoperative 1-month |
| Micronutrients' deficiency | iron, ferritin, calcium, phosphate, albumin, vit.B12, vit.D, and parathyroid hormone | postoperative 1-year |
| body composition change | bioelectrical impedance analysis and fat measurement CT | postoperative 1-year |
| cost-effectiveness | cost-utility analysis using lifetime expected costs and quality-adjusted life years (QALYs) | postoperative 1-year |
| Park 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |