Efficacy and Safety of Bariatric Surgery for Korean Morbidly Obese Patients : Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- body weight (cm) change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •body mass index (BMI) ≥ 35 kg/m2 or BMI ≥ 30 kg/m2 with co-morbidities such as hypertension, glucose intolerance, dyslipidemia, and sleep apnea
- •being suitable for general anesthesia
- •being able to give informed consent and committed to follow-up
- •Female patients should have a negative urine pregnancy test at screening and agree to use reliable method of contraception for 1 year.
排除标准
- •prior bariatric surgery of any kind
- •being unable to understand the risks, benefits and compliance requirements of this trial
- •pregnancy or planning on being pregnancy
- •non-Korean speaker
- •American society of anesthesiology (ASA) class IV or higher
- •malignancy within 5 years.
研究组 & 干预措施
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.
干预措施: Sleeve gastrectomy or Roux-en-Y gastric bypass (Other)
结局指标
主要结局
body weight (cm) change
时间窗: postoperative 1-year
waist circumference (cm) change
时间窗: postoperative 1-year
次要结局
- body composition change(postoperative 1-year)
- remission rates of obesity-related co-morbidity (hypertension, type 2 diabetes, dyslipidemia, and sleep apnea)(postoperative 1-year)
- Quality of life change(postoperative 1-year)
- Morbidity(postoperative 1-year)
- Mortality(postoperative 1-month)
- Micronutrients' deficiency(postoperative 1-year)
- cost-effectiveness(postoperative 1-year)
研究者
Do Joong Park
Professor
Seoul National University Bundang Hospital