The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 410
- 试验地点
- 3
- 主要终点
- the quality of visualization of the small bowel
研究概览
简要总结
The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.
排除标准
- •Age < 18 or > 75 years
- •Known or suspected GI stricture or fistula
- •A history of GI tract resection
- •Swallowing disorders
- •Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus
- •Medications that could affect gastrointestinal movement within one week
- •Implanted with a medical electronic device
- •Active inflammatory bowel disease, toxic megacolon, toxic colitis
- •Severe pulmonary, cardiac, renal, or hepatic disease
- •Uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg);
- •Disturbance of electrolytes
- •Pregnancy or lactation
- •Patients inability to provide written voluntary informed consent
- •Participation in another clinical study
研究组 & 干预措施
Group A
Fast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel).
干预措施: capsule endoscopy (Device)
Group B
the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: polyethylene glycol (Drug)
Group B
the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: capsule endoscopy (Device)
Group C
the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: polyethylene glycol (Drug)
Group C
the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: capsule endoscopy (Device)
Group D
Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: polyethylene glycol (Drug)
Group D
Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: capsule endoscopy (Device)
Group E
Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: polyethylene glycol (Drug)
Group E
Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system.
干预措施: capsule endoscopy (Device)
结局指标
主要结局
the quality of visualization of the small bowel
时间窗: one week after CE procedure
The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of "excellent" is at least 90% of the overall small bowel mucosa is clean (the sum of "clean" time /total small bowel transit time\>90%). And the definition of "good" is at least 80% of the overall small bowel mucosa is clean. We considered that "excellent" or "good" preparation is adequate to make an accurate diagnosis.
次要结局
- diagnostic rate(one year)
- patient acceptability(day of CE procedure)
研究者
Zhizheng Ge
MD
Shanghai Jiao Tong University School of Medicine