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Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

2010年2月4日 更新者:Maltepe University

Prospective Randomized Comparison of Oral Sodium Phosphate and Sennoside A+B Calcium Lavage for Colonoscopy Preparation

The aim of the investigators study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

研究概览

地位

完全的

详细说明

Colorectal cancer is a leading cause of death from cancer. Because colonic cancer begins as a small adenoma that , evolves into carcinoma over a decade or more pre-emptive colonoscopic polypectomy can prevent this malignancy. For a good colonoscopic examination ideally the colon should be cleansed of all fecal material because poor bowel preparation before colonoscopy often leads to inability to reach the cecum or poor visualization of the mucosa . Thus , pathology may be missed, repeat examinations may be scheduled at earlier intervals than planned and the procedure is more difficult and time consuming. In addition , poor bowel preparation can increase the risk of significant complications. Perforations resulting from maneuvers has greater consequences in the setting of inadequate bowel preparation.

In the past two decades , various bowel preparation methods have been proposed including castor oil, anthraquinones, phenolphtalein and magnesium citrate, in combination with low residue diet4-7. Along these agents , cleansing enemas formed the traditional bowel preparation. Oral sodium phosphate (Fleet Phospo-soda, C.B Fleet Co, Inc., Lynchburg, Va.)(NaP) a preparation containing dibasic and monobasic sodium phosphate was proven to be cost effective and has since been used worldwide8,9. NaP osmotically draws plasma water into the bowel lumen to promote bowel cleansing. NaP must be accompanied by significant oral fluid to prevent dehydration. Patients with compromised renal function, dehydration, hypercalcemia or hypertension with the use of angiotensin converting enzyme inhibitors have experienced phosphate nephropathy after use of oral NaP solutions.

Senna laxatives containing sennosides activated by colonic bacteria have a direct effect on intestinal mucosa increasing the rate of colonic motility , enhancing colonic transit, and inhibiting water and electrolyte secretion10. Sennosides may result in hypokalemia and atonic colon.

The aim of our study is to assess the bowel cleansing effects of two different agents and to compare their safety of application, ease of usage and effects on serum electrolytes.

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Ninety-nine patients requiring diagnostic outpatient colonoscopy were prospectively recruited for the study and randomized by internet based Easy sample random numbers software program to two arms of sodium phosphate versus Sennosid A+B calcium preparation.

描述

Inclusion Criteria:

  • Patients requiring diagnostic outpatient colonoscopy.
  • Over the age of 18 and giving informed consent by their will.

Exclusion Criteria:

  • Patients unable to give informed consent
  • Those younger than 18 years old
  • Those with a known history of chronic renal failure
  • Pregnant women and those with a known history of bowel resection were excluded

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
Colonic cleansing was evaluated by using the amount and consistency of stool remained in the colonic segment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究注册日期

首次提交

2010年1月26日

首先提交符合 QC 标准的

2010年1月26日

首次发布 (估计)

2010年1月27日

研究记录更新

最后更新发布 (估计)

2010年2月5日

上次提交的符合 QC 标准的更新

2010年2月4日

最后验证

2009年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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