Korean OBEsity Surgical Treatment Study(KOBESS-II) : Protocol of a Prospective Multicenter Cohort Study on Morbid Obesity Patients Undergoing Sleeve Gastrectomy Versus Roux-en Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Body weight change rate
研究概览
简要总结
Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity patients(BMI over 35)
- •morbid obesity patients(BMI over 30) with cardiovascular disease, hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea
- •type 2 diabetes mellitus obesity patients(BMI over 27.5) who were treated medical therapy or HbA1C level over 7%
排除标准
- •Patients who underwent previously bariatric operation
- •Patients who were diagnosed malignant disease patients within 5 years
- •Patients who were involved with other clinical trial within 3 months
- •Patients who are risky to conduct general anesthesia for operation
结局指标
主要结局
Body weight change rate
时间窗: Postoperative 1 year
Decreased body weight proportion compare to preoperative body weight
Obesity Cure Success Rate
时间窗: Postoperative 1 year
Proportion of patients who reach BMI bellow 25
Waist circumference change rate
时间窗: Postoperative 1 year
Decreased waist circumference change proportion compare to preoperative waist circumference
次要结局
- Quality of life improvement rate and degree-2(Postoperative 1 year, 2 year)
- Postoperative complication rate and mortality rate(Within postoperative 30 days)
- Quality of life improvement rate and degree-4(Postoperative 1 year, 2 year)
- Quality of life improvement rate and degree-3(Postoperative 1 year, 2 year)
- Quality of life improvement rate and degree-1(Postoperative 1 year, 2 year)
- Rate of morbid disease remission or partial remission(Postoperative 1 year, 2 year)
- Micronutrient deficiency(Postoperative 1 year, 2 year)
- Quality of life improvement rate and degree-5(Postoperative 1 year, 2 year)
研究者
Yoonseok Heo
Professor
Inha University Hospital