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临床试验/NCT00750763
NCT00750763已完成4 期

A Prospective Audit of Tolerability, Mucosal Cleansing Efficacy and Mucosal Abnormalities Associated With Standard Orally Administered Colon Cleansing Preparations for Colonoscopy

Fremantle Hospital and Health Service1 个研究点 分布在 1 个国家目标入组 676 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
676
试验地点
1
主要终点
To assess which bowel preparation provides the best colon cleansing using a validated score and is best tolerated by patients.

研究概览

简要总结

Colonoscopy is the gold standard investigation for assessing the lining of the colon. Colon cleansing preparations are required to be taken prior to colonoscopy to provide effective visualisation and identification of any abnormalities and different types of colon cleansing preparations exist.

Some colon cleansing preparations have been shown to cause visible changes in the lining of the bowel which may cause confusion and incorrect diagnoses to be made.

This audit aims to assess the ability of different colon cleansing preparations to clear the colon of faeces. The tolerability of each will also be assessed, as will any changes in the lining of the bowel to assess if one type of colon preparation is more likely to cause visible changes than another.

详细描述

There are several published trials of different colon cleansing agents for colonoscopy (which is the investigation of choice for visualisation of the colonic mucosa) which compare different regimens. However, a recent published meta-analysis has shown that most audits and studies were underpowered with poor study design and so no consensus on the most effective preparation exists1. 10-20% of failed colonoscopy is attributable to inadequate bowel cleansing which has a negative impact on the detection of potential malignant lesions in the colon3 as well as requiring the patient to attend again for further colonoscopy after repeated colon cleansing which also impacts on waiting lists and healthcare costs.

Colon cleansing preparations can be broadly classified into three groups. Osmotic laxatives such as sodium phosphate (NaP) increase colon water content by attracting extracellular fluid efflux through the bowel wall. Polyethylene glycol (PEG) laxatives are high molecular weight non-absorbable polymers that are administered in a dilute electrolyte solution, this is retained in the colon where it acts as a bowel cleanser without any significant fluid exchange across the colonic mucosa. The third group are stimulant laxatives such as senna or sodium picosulphate which work primarily by enhancing smooth muscle contractility and also they may increase bowel water content.

Previous published audits and studies comparing different types of colon cleansing preparations have been limited by small sample size with only 5 published papers having over 100 patients in each arm of the study. These 5 studies suggest that NaP may be better than PEG but the recent meta-analysis failed to show this, primarily due to the large number of smaller studies showing PEG was better than NaP. Interpretation of the studies is limited by inconsistent and poorly defined measures of efficacy outcome. Most studies have used a subjective endoscopists assessment of the overall quality of the bowel preparation making comparisons between studies impossible. Recently a calibrated externally validated outcome assessment tool has been developed to objectively quantify the quality of bowel preparation4, but no randomised published study has yet utilised this tool.

In the absence of clear difference in efficacy between preparations then patient tolerability is likely to be an important distinguishing feature when selecting a treatment. Data on tolerability outcomes is limited but there is some evidence that PEG solutions are less well tolerated due to the volume of liquid required to drink. This is an area where further study is needed.

The ability of a colonic cleansing preparation to clean the colon effectively also must be balanced by its ability to not induce changes in the lining of the bowel itself. Ulceration and inflammation of the colon has been shown to occur in 3-24% of patients using NaP compared with 1-2% in those receiving PEG. Such findings can be mistaken for inflammatory bowel disease such as Crohns or put down to drug induced changes such as non steroidal anti inflammatory agents (NSAIDs). However, these studies have been either non randomised5 or underpowered to detect real differences.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who are referred to undergo ambulatory colonoscopy at Kaleeya Hospital would be entered into the study

排除标准

  • Prior history of inflammatory bowel disease or suspected inflammatory bowel disease, or patients on current non steroidal antiinflammatory medication (excluding low dose aspirin). These patients may have mucosal inflammation/ulceration which would prevent analysis of mucosal abnormalities due to the colon cleansing agent and so would not be studied.
  • Patients with heart failure (NYHA >2) or renal failure (GFR<30) (since fluid shifts associated with sodium phosphate bowel preparation have been reported).
  • All patients over the age of 75 due to potential dehydration and hyperphosphatemia from the bowel preparations.

研究组 & 干预措施

1

Active Comparator

PEG (Colonlytely) - 4 litres

干预措施: Colonlytely (Drug)

2

Active Comparator

Picosulphate (Picolax/Picoprep) - 2 sachets

干预措施: Picolax/Picoprep (Drug)

3

Active Comparator

Sodium Phosphate (Fleet) - 2 bottles

干预措施: Fleet (Drug)

结局指标

主要结局

To assess which bowel preparation provides the best colon cleansing using a validated score and is best tolerated by patients.

时间窗: At time of colonoscopy

次要结局

  • To assess the incidence of mucosal inflammation/ulceration induced by each colon cleansing agent.(At time of colonscopy)

研究者

申办方类型
Other

研究点 (1)

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