Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- % Excess Body Weight Loss (%EWL)
研究概览
简要总结
The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.
详细描述
Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.
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
- 否
入选标准
- •Body Mass Index (BMI) > 35
- •Meet ASMBS and NIH criteria for Weight Loss Surgery
- •ASA Class I - III
- •Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
- •English speaking & comprehension
- •Normal mental caliber.
排除标准
- •Pregnancy, Liver failure or Kidney failure
- •Women of childbearing potential lactating at the time of initial consult or at the time of surgery
- •Any condition which precludes compliance with the study
- •History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.
结局指标
主要结局
% Excess Body Weight Loss (%EWL)
时间窗: 6 months post procedure
Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.
次要结局
- HgbA1c(12 months post procedure)
研究者
Allison Barrett
Principal Investigator
Northwell Health