Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Change in BMI
研究概览
简要总结
This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbid obese patients aged from 18-65,
- •BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.
排除标准
- •psychiatric illness,
- •substance abuse,
- •previous gastrointestinal surgery, and
- •any patient who transfers from laparoscopic to convention procedure.
结局指标
主要结局
Change in BMI
时间窗: from baseline to 2-year postoperation
Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)\^2
Change in Body Weight
时间窗: baseline to 2-year postoperation
Change of body weight in Kilograms measured at follow-up visits two year after surgery
次要结局
未报告次要终点
研究者
Shahzeer Karmali
BSc, MD, FRCSC
University of Alberta