A Prospective Study to Evaluate the Safety and Efficacy of the Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Percent of excess weight loss
研究概览
简要总结
The purpose of this study is to collect data prospectively on the safety and efficacy of the Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.
The 95% confidence interval for average percentage of weight loss and body mass index will be computed at 6 months, one year and then annually. Analysis of comorbid conditions changes, quality of life and adverse events will be performed. With 50 subjects in the study, limited power is expected and no formal hypothesis testing will be performed.
详细描述
The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with other restrictive procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 60 years
- •BMI 35-39.9 kg/m2 with one or more severe co-morbid conditions or BMI 40-55 kg/m2
- •Willingness to comply with dietary restrictions required by the protocol
- •History of obesity for at least 5 years
- •History of at least 6 months of documented failures with traditional non-surgical weight loss methods
- •Willingness to follow protocol requirements which include: signing the informed consent form, completing routine follow-up visits for the study duration, and completing all pre- and post-operative laboratory and diagnostics tests in addition to the quality of life questionnaire
- •If female with childbearing potential, using an appropriate form of contraception
排除标准
- •Age less than 18, age greater than 60
- •Pregnancy
- •History of major depressive disorder or psychosis
- •Previous bariatric surgery or previous gastric surgery
- •Presence of achalasia
- •Any condition that, in the judgment of the investigator, would place a subject at undue risk, or could potentially compromise the results or interpretation of the study
结局指标
主要结局
Percent of excess weight loss
时间窗: 3 years
The primary efficacy variable is weight loss, which is measured in pounds and evaluated in terms of % excess weight loss (EWL) and body mass index (BMI), both of which will be measured at each follow-up visit. Percent EWL is calculated by the following equation: \[Weight Lost\]/ \[(Pre-op Weight)-(Ideal Body Weight)\]. BMI is calculated by the equation: Weight (kg) divided by Height (m) squared \[kg/m2\].
次要结局
- Status of comorbid conditions(3 years)
- Changes in quality of life scores from base line(3 years)
- Adverse events(3 years)
研究者
Jaime Ponce MD
Director for Bariatric Surgery
Ponce, Jaime, M.D.