Assessment of Combined Bowel Preparation for Capsule Endoscopy Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy
研究概览
简要总结
The investigators are conducting a study to see if taking a bowel preparation before having a capsule endoscopy is more helpful than the standard preparation of not eating after 7 PM the night before a capsule endoscopy in making it easier to see the small bowel in order to find the source of gastrointestinal bleeding.
详细描述
This is a single-blind, prospective randomized controlled study to determine if a combination of purgative agent, prokinetic agent, simethicone, and position will improve small bowel visualization, diagnostic yield, and completion rate of capsule endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Gastrointestinal bleeding as indication for capsule endoscopy.
- •Ability to give informed consent
排除标准
- •Subject has an allergy to polyethylene glycol or other adverse reaction to a previous bowel preparation with PEG3350 (MoviPrep®), metoclopramide, or simethicone;
- •Subjects has gastrointestinal motility disorder;
- •Subjects had stomach or small bowel resection;
- •Subjects has pheochromocytoma;
- •Subjects has uncontrolled hypertension;
- •Subjects has seizure disorders;
- •Subjects has concurrent MAO inhibitor use;
- •Subject has G6PD deficiency;
- •Subjects has swallowing disorder (including impaired gag reflex);
- •Subjects has hyponatremia with serum sodium less than 130 mm0l/L
研究组 & 干预措施
Combination Prep
The other group will receive the combination bowel preparation, which consists of taking the standard bowel preparation plus:
- drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
- drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
- drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
- lying on your right side for 30 minutes following the swallowing of the capsule endoscope.
干预措施: Combination Prep (Drug)
结局指标
主要结局
Improvement small bowel visualization, diagnostic yield, and complete rate of capsule endoscopy
时间窗: 1 year
The primary endpoints of small bowel visualization quality, diagnostic yield, and completion rate will be compared between groups using Pearson's chi-square test.
次要结局
- gastric transit time(1 year)
- Safety outcomes and Patient satisfaction(1 year)
研究者
Stephanie L. Hansel
Assistant Professor of Medicine
Mayo Clinic