Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korean Center for Disease Control and Prevention | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass
This is prospective cohort study. Total 400 obese patients will be enrolled(Sleeve gastrectomy 200 patients, Roux-en-Y gastric bypass 200)
The principal investigator or another clinical investigator in charge will individually inform the patients about the study, before operation at out patient clinic. At that time patient is selected to either sleeve gastrectomy group or Roux-en-Y gastric bypass group. All investigator report to clinical research center about patients BMI and operation method.
About 30-35 obesity patients will be enrolled according to their BMI status. Patients' BMI status is classified into several parts by 2.5 gap started from 27.5.
All patients will undergo periodically anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofiberscopy, polysomnography and abdomen CT before and after surgery.
Patients with hypertension will undergo echocardiography. Patients with polycystic ovary syndrome will be checked hormonal study. Patients with type 2 diabetes mellitus will be performed 75g oral glucose tolerance test test.
Surgical complication include wound morbidities, gastrointestinal leakage or fistula, postoperative bleeding, intra-abdominal abscess, stricture , adhesive ileus, reflux esophagitis, marginal ulceration, dumping syndrome and internal hernia.
Systemic complication which is not associated with the operation field include ling morbidities, heart morbidities, urinary morbidities and others.
Hospital mortality is defined as postoperative death form any cause within 30 days after operation.
All patients will be followed up post operative 1 month, 3 month, 6 month, 12 month, 18 month, 24 month.
All patients' liver tissue, visceral fat and subcutaneous fat will be harvested during operation.
All patients' blood sample will be collected at out patient clinic visit. All patients' urine and face will be collected at out patient clinic visit and will be analyzed to evaluate microbial change throughout pre and post operation period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve gastrectomy | Experimental | 200 obesity patients who undergo laparoscopic sleeve gastrectomy |
|
| Roux-en-Y gastric bypass | Experimental | 200 obesity patients who undergo laparoscopic Roux-en-Y gastric bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy | Procedure | Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Obesity Cure Success Rate | Proportion of patients who reach BMI bellow 25 | Postoperative 1 year |
| Body weight change rate | Decreased body weight proportion compare to preoperative body weight | Postoperative 1 year |
| Waist circumference change rate | Decreased waist circumference change proportion compare to preoperative waist circumference | Postoperative 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of morbid disease remission or partial remission | Remission rate or partial remission rate of morbid disease related to obesity such as hypertension, type 2 diabetes mellitus, hyperlipidemia after surgery | Postoperative 1 year, 2 year |
| Postoperative complication rate and mortality rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoon Seok Heo, Professor | Contact | +82-32-890-3437 | gsheo@inha.ac.kr | |
| Yun Suk Choi, Instructor | Contact | +82-32-890-3437 | yunsukki@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yoon Seok Heo, Professor | Inha University Hospital | Principal Investigator |
| Do Joong Park, Professor | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Recruiting | Incheon | South Korea |
Not provided
Comparative double arm study
Not provided
Not provided
Not provided
Not provided
| Roux-en-Y gastric bypass | Procedure | Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure. |
|
Number of participants surgical complications associate with the surgical technique or the operation field Number of participants mortality after operation associated with surgical complication or underlying disease |
| Within postoperative 30 days |
| Micronutrient deficiency | Incidence of micronutrient deficiency rate such as vitamine, calcium, iron | Postoperative 1 year, 2 year |
| Quality of life improvement rate and degree-1 | Patients rate and quantitative analysis of the improved life quality using several survey EQ-5D-3L(EuroQol-5D) consists of 5 dimensions(mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each of which is scored as no/some/extreme problems. The dimension scores are converted into health utility scores ranging form 0(death) to 1(perfect health) | Postoperative 1 year, 2 year |
| Quality of life improvement rate and degree-2 | EQ-VAS(EuroQol-Visual Analogue scale) is a question scale ranging form 0 to 100. 0 indicated the worst and 100 indicated the best condition. EQ-VAS provides important, complementary information on patient's view about their own health. | Postoperative 1 year, 2 year |
| Quality of life improvement rate and degree-3 | Impact of Weight on QoL(IWQoL) has 5 dimensions and each dimension has several items.
Score range from 0 to 100 and 100 represents the best quality of life. | Postoperative 1 year, 2 year |
| Quality of life improvement rate and degree-4 | Moore-head-Ardelt QoL questionnaire II(MA-II) has 6 items(general self-esteem, physical activity, social contacts, satisfaction concerning work, pleasure related to sexuality and focus on eating behavior). All items are scored according to 10-level Likert scale(-0.5 to 0.5) and all have the same weight. | Postoperative 1 year, 2 year |
| Quality of life improvement rate and degree-5 | Obesity-related Psychosocial Problem scale(OP scale) consists of 8 items that measure the bothersome impact of body weight on given situations. (private gatherings in their own home, private gatherings at their friend or relative's home and going to restaurant) | Postoperative 1 year, 2 year |
| Yong Suk Park, Professor |
| Seoul National University Bundang Hospital |
| Study Director |
| Seung Wan Ryu, Professor | Keimyung University Hospital | Study Director |
| Moon Won Yoo, Professor | Ulsan univertisy Seoul Asan Medical Center | Study Director |
| Han Hong Lee, Professor | The Catholic University of Korea | Study Director |
| Ji Yeon Park, Professor | Kyungpook National University Hospital | Study Director |
| Sang Hyun Kim, Professor | Soonchunhyang University Hospital | Study Director |
| Jong Won Kim, Professor | Chung-Ang University Hopspital | Study Director |
| Jong Han Kim, Professor | Korea University Medical Center(Guro Hospital) | Study Director |
| In Seob Lee, Professor | Ulsan univertisy Seoul Asan Medical Center | Study Director |
| In Gyu Kwon, Professor | Yonsei University Medical Center(Gangnam Hospital) | Study Director |
| Tae Kyung Ha, Professor | Hanyang University | Study Director |
| Sung Il Choi, Professor | Kyung Hee University Hospital at Gangdong | Study Director |
| Kyung Won Seo, Professor | Kosin University Gospel Hospital | Study Director |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D009765 | Obesity |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
Not provided
Not provided