NCT06298162已完成不适用
Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pouch emptying rate measured with MRI
研究概览
简要总结
A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL>35%) and bad responders (TWL<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 20 and 55 years
- •Patients must be able to adhere to the study visit schedule and protocol requirements
- •Patients must be able to give informed consent (IC) prior to any study procedures
- •Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
- •Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician
排除标准
- •Diabetes Mellitus
- •Menopausal
- •Gastrointestinal problems, gastric or intestinal diseases
- •Drug or alcohol addiction
- •Inability to stop smoking during the overnight fasting period
- •Pregnant or lactating
- •Having an intolerance or allergy for one of the components of the test product
- •Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
- •Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
- •Having a contra-indication to MRI scanning (including, but not limited to):
- •Pacemakers and defibrillators
- •Intraorbital or intraocular metallic fragments
- •Ferromagnetic implants
结局指标
主要结局
Pouch emptying rate measured with MRI
时间窗: Two years after LRYGB
次要结局
- subjective ratings of wellbeing(Two years after LRYGB)
- subjective ratings of fullness(Two years after LRYGB)
研究者
研究点 (1)
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