NCT03236142招募中不适用
The Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS) Results in Less Nutritional Deficiencies Than the Standard Duodenal Switch (DS) Operation: A Multicenter, Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Vitamin A Deficiency
研究概览
简要总结
The aim of this study is to answer the question of whether the single anastomosis, 300 cm loop, duodenal switch (SIPS) is an equally effective, safe, simpler operation with less nutritional and surgical risks than the standard duodenal switch (DS) operation. Please note, this study does not provide a stipend or coverage for surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 40 to 65
- •Agree to not use weight loss medications for the length of the study
- •Compliance with standards of surgical program
排除标准
- •Patients with a history of previous bariatric surgery except for patients who have had a previous gastric sleeve
- •Previous complex abdominal surgery
- •Poorly controlled medical or psychiatric disease
研究组 & 干预措施
Standard Duodenal Switch (DS)
Active Comparator
干预措施: Standard Duodenal Switch Operation (Procedure)
Single Anastomosis, 300 cm Loop, Duodenal Switch (SIPS)
Experimental
干预措施: SIPS Operation (Procedure)
结局指标
主要结局
Vitamin A Deficiency
时间窗: 36 months post surgery
Proportion of patients with a vitamin A deficiency
次要结局
- Body Mass Index (BMI)(36 months post surgery)
- Percentage of excess weight lost(36 months post surgery)
- Vitamin D, zinc, copper, and albumin(36 months post surgery)
- Frequency of stools(36 months post surgery)
- Length of Operation(Date of operation)
研究者
Stephan Myers, MD
Stephan Myers, MD, FACS, Medical Director, Principal Investigator
Reading Health System
研究点 (2)
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