Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Completeness rate
研究概览
简要总结
The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.
详细描述
Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.
This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.
All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.
The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Subject referred for clinical colon/panenteric examination
- •Subject received an explanation about the nature of the study and agreed to provide written informed consent
排除标准
- •Subject with dysphagia or any swallowing disorder
- •Subject with a prior stomach, small bowel, or colonic resection
- •Subject with severe renal insufficiency
- •Subject with any allergy or other known contraindication to the medications used in the study
- •Women who are either pregnant or nursing
- •Subject suffers from life threatening conditions
研究组 & 干预措施
Optimized preparation regimen
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster
干预措施: polyethylene glycol + ascorbic acid (Drug)
Optimized preparation regimen
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster
干预措施: magnesiumoxid + sodium picosulfate (Drug)
Optimized preparation regimen with prucalopride
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride
干预措施: polyethylene glycol + ascorbic acid (Drug)
Optimized preparation regimen with prucalopride
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride
干预措施: magnesiumoxid + sodium picosulfate (Drug)
Standard preparation regimen
4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster
干预措施: sodium phosphate (Drug)
Standard preparation regimen
4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster
干预措施: polyethylene glycol (Drug)
Optimized preparation regimen
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster
干预措施: gastrografin (Drug)
Optimized preparation regimen with prucalopride
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride
干预措施: gastrografin (Drug)
Optimized preparation regimen with prucalopride
1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride
干预措施: prucalopride (Drug)
结局指标
主要结局
Completeness rate
时间窗: Within 3 months after completed capsule colonoscopy
Visualization of the hemorrhoidal plexus or an excreted capsule
Adequate cleanliness rate
时间窗: Within 3 months after completed capsule colonoscopy
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale
次要结局
- Transit times(Within 3 months after completed capsule colonoscopy)
- Diagnostic yield(Within 3 months after completed capsule colonoscopy)
- Assessment of patient tolerance of the bowel preparations(Within 3 months after completed capsule colonoscopy)