Achievement of Better Examinee Compliance on Colon Cleansing Before Colonoscopy Without Sacrificing Cleansing Effect - A Multi-Center Endoscopist-Blinded Randomized Trial Using Commercialized Low-Residue Diet
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 5
- 主要终点
- Colon cleansing level
研究概览
简要总结
Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to 2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those with normal BMI or body weight.The main cause of poor patient compliance includes abdominal pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet restriction with low-fiber diet is always advised to every screen before colonoscopy, the extent of diet restriction is widely variable and thus influences the degree of colon cleansing.
With commercialized low-residue diet (CLRD), diet restriction will be well controlled and variability of colon cleansing can be minimized such that guarantee a colonoscopy with good quality. In this RCT, we will compare the compliance of screen during colon cleansing using different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.
详细描述
Setting: A multi-center study including the following teaching hospitals:
National Taiwan University Hospital, Taipei Taipei Medical University Hospital, Taipei E-Da Hospital, Kaohsiung Buddhist Tzu-Chi General Hospital, Taipei En Chu Kong Hospital, Taipei Far Eastern Memorial Hospital, Taipei
Study design: RCT, single blinded
Study subjects:
Inclusion criteria: Subjects who receives colonoscopy for screening or for clinical purpose Exclusion criteria: Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who receives colonoscopy for screening or for clinical purpose
排除标准
- •Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
结局指标
主要结局
Colon cleansing level
时间窗: At the timing of colonoscopy
次要结局
- adenoma detection rate(At the timing of colonoscopy)
- Cecal intubation time(At the timing of colonoscopy)
- Patient compliance including abdominal symptoms during colon cleansing, bowel movement on the way to hospital(-2hr)
- Whole procedural time(At the timing of colonoscopy)
