NCT00693290Unknown不适用
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clarity of the mucosa evaluated by the Ottawa Scale.
研究概览
简要总结
Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure.
The principal research questions are:
- Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
- Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
- Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up?
- Does body weight affect perceived tolerability of either group?
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients attending for Colonoscopy.
- •Patients referred for colonoscopy via General Practitioner.
排除标准
- •Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
- •Previous episodes of total or partial small bowel obstruction
- •Previous colonic surgery
- •Known swallowing disorder
- •Pregnancy
- •Extremes of age (Less than 16 or greater than 80)
- •Small Intestine disorders
- •Renal Insufficiency (Serum Creatinine> 110)
- •Congestive Heart failure
- •Presence of ascites
- •Severe Colitis
结局指标
主要结局
Clarity of the mucosa evaluated by the Ottawa Scale.
时间窗: At endoscopy screening
次要结局
- Concordance with the bowel preparation.(Prior to the endoscopy)
研究者
研究点 (2)
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