Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Number of participants with postoperative morbidity
研究概览
简要总结
The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).
The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.
详细描述
Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable.
Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America.
The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •body mass index of 40-55 kg/m2
- •agreed to participate in this study with informed consent signed
排除标准
- 未提供
结局指标
主要结局
Number of participants with postoperative morbidity
时间窗: up to 5 years
determine any morbidity related to the surgical procedure through the 5 years follow up
Change from Baseline weight assessed at different time points to determine maximal weight loss,
时间窗: 3,6,9 months and 1,2,5 years
determine changes in weight loss through 5 years follow up, measuring maximal weight loss.
Changes in weight assessed at different time points to determine weight regain
时间窗: 3,6,9 months and 1,2,5 years
identify changes in weight regain during the postoperative 5 years follow up
次要结局
未报告次要终点
研究者
Miguel F Herrera
Miguel F. Herrera, M.D., Ph.D., Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran