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临床试验/NCT01454388
NCT01454388已完成4 期

A Randomized Controlled Trial Comparing Breakfast Versus no Breakfast

Queen's University1 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
496
试验地点
1
主要终点
bowel cleansing efficacy

研究概览

简要总结

In addition to bowel cleansing agents, the current practice of bowel preparation for colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day before the procedure. This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their bowel preparation. Patients requiring outpatient colonoscopies will be asked to participate. They will be randomized to either breakfast or no breakfast the day before the procedure. Colon cleanliness, patient hunger, and tolerance will be assessed.

The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated

详细描述

Colon cleansing prior to colonoscopy is essential for an adequate examination. Research has shown that preparation prior to colonoscopy remains one of the biggest deterrents for patients considering colon screening (1).

In addition to the bowel cleansing agents another important aspect of the preparation is the diet consumed prior to the procedure. Currently 48 hours prior to colonoscopy patients are asked to consume a low residue diet. The day before the procedure they are switched to a clear fluid only diet which many patients find difficult to follow due to hunger and can lead to non-compliance with the preparation.

There have been no trials to date which have answered the question whether the consumption of breakfast alters colon cleansing with the cleansing agents currently used in Canada. Investigators found that in patients receiving sodium phosphate preparations, a full breakfast or low residue lunch had no effect on colon cleansing scores and improved hunger and energy levels (2). Several studies have looked at the result of low residue diet kits taken the day prior to the procedure and showed no difference in colon cleansing or tolerability compared to the traditional clear fluid regime (3,4).

This study aims to test whether patients who consume a low residue breakfast the day prior to colonoscopy have a difference in the quality of their colon cleansing or tolerability of the preparation compared to those who consume a clear fluid diet. The investigators hypothesize that there will be no difference in bowel preparation scores and will be better tolerated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients for whom a GI physician has ordered a colonoscopy will be approached for inclusion in the trial

排除标准

  • •ileus or bowel obstruction -significant constipation (<3 spontaneous bowel movements/day)- previous colorectal surgery
  • •active inflammatory bowel disease
  • •pregnancy
  • •recent (<6 months) myocardial infarction or unstable angina

研究组 & 干预措施

PEG plus breakfast

Active Comparator

patients are allowed to have a low residue breakfast the day prior to colonoscopy

干预措施: breakfast (Other)

PEG without breakfast

No Intervention

picosalax plus breakfast

Active Comparator

patients are allowed to have a low residue breakfast the day prior to colonoscopy

干预措施: breakfast (Other)

picosalax without breakfast

No Intervention

结局指标

主要结局

bowel cleansing efficacy

时间窗: 2 days

Quality of bowel cleansing as measured by Ottawa Bowel Scale

次要结局

  • Hunger(day of colonoscopy (day 1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Lawrence Hookey

Principal Investigator

Queen's University

研究点 (1)

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