Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.
详细描述
This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age older than 18 years
- •Morbidly Obese
- •BMI >40 or
- •BMI >35 plus co-morbid obesity related disease conditions
- •Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
- •Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi
排除标准
- •Any patient not meeting the inclusion criteria
- •Patients with any major medical problems contraindicating surgery
- •Patients with a medically treatable cause of obesity
- •Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
- •Alcohol or drug addiction
- •Established infection anywhere in the body at the time of surgery
- •Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
- •Family or patient history of autoimmune disease
结局指标
主要结局
Weight loss
时间窗: at least 1 year
Weight loss 4 weeks post surgical:20% additional than without plication, 3months post surgical: 30% additional than without plication, 6 months post surgical:30-40% additional than without plication, 1 year post surgical = 30-40% additional than without plication \& at 1 year patient will require 50% fewer adjustments than without plication.
次要结局
未报告次要终点