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临床试验/NCT01045499
NCT01045499已完成不适用

Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents

Jeffrey L Zitsman, MD1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2005年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
137
试验地点
1
主要终点
Percentage of Excess Weight Change (EWL)

研究概览

简要总结

Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.

详细描述

Seventy to ninety-eight percent of obese children become obese adults. Comorbidities of obesity such as type II diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. The only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. The investigators believe that the best initial bariatric surgical option for adolescents is LAGB because of its low complication rates, adjustability, and reversibility. Obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of LAGB as measured by % excess weight loss, decreased % body fat, decreased body mass index (BMI), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. Eligible patients will have been followed for 6 months by physicians in the Center for Adolescent Bariatric Surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. Following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered LAGB.

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
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ages 13-17 upon entry
  • •BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension

排除标准

  • •severe psychiatric illness
  • •eating disorder with purging
  • •previous weight loss surgery
  • •stated inability to comply with pre-op and post-op visits

研究组 & 干预措施

laparoscopic gastric banding

Experimental

Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.

干预措施: Laparoscopic adjustable gastric banding (Allergan Lap Band) (Device)

结局指标

主要结局

Percentage of Excess Weight Change (EWL)

时间窗: Baseline and up to 5 years from start of study.

Weight change evaluated in terms of % excess weight loss (EWL).

次要结局

  • Percentage of Excess BMI Change(Baseline and up to 5 years from start of study.)

研究者

发起方
Jeffrey L Zitsman, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeffrey L Zitsman, MD

Professor of Surgery

Columbia University

研究点 (1)

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