NCT00677794已完成4 期
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- small bowel cleansing
研究概览
简要总结
There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.
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
- •patients undergoing VCE.
排除标准
- •bowel obstruction or ileus;
- •known stricture or fistula;
- •previous small bowel surgery;
- •severe gastroparesis or motility disorder
- •renal impairment (serum creatinine over normal range within three months of study);
- •congestive heart failure;
- •cirrhosis;
- •implanted cardiac pacemaker or defibrillator or other electromedical device;
- •pregnancy.
研究组 & 干预措施
3
Active Comparator
Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE).
干预措施: Polyethylene glycol (Drug)
1
Active Comparator
Clear fluids only after lunch.
干预措施: Clear fluids (Drug)
2
Active Comparator
Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE).
干预措施: Picosalax (Drug)
结局指标
主要结局
small bowel cleansing
时间窗: during exam
次要结局
- yield of Video Capsule Endoscopy (VCE) in iron deficiency(during study)
- effect of preparation on blood chemistry(24 hours after ingestion)
- tolerance of preparation(during preparation)
研究者
Dr. Lawrence Hookey
Associate Professor
Queen's University
研究点 (1)
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