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临床试验/NCT00748293
NCT00748293Unknown不适用

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

National Taiwan University Hospital5 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2008年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (5)

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