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临床试验/NCT06426745
NCT06426745已完成不适用

Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
colon cleansing

研究概览

简要总结

Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions.

详细描述

Colonic cancers are a major concern in the Middle East and the world in general, and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development. From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies, 693 were incomplete (7.8%), and for 25% of failure was because of inadequate bowel preparation.

An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients. The polyethylene glycol (PEG) solution, an isosmotic non-absorbable polymer, is generally used for bowel preparation, because of its safety, effectiveness, and good tolerability. Quality of bowel cleansing depends not only on the formula used, but the preparation regimen also plays a role. Split dosing of the laxative offers, in general, better cleansing than a single dose preparation.

A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation.

Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose, in terms of adequate bowel preparation and polyp detection.

On the other hand , a large randomized trial of PEG regimens show, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose. Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated, and acceptable bowel preparation for colonoscopy.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- All patients undergoing elective colonoscopy

排除标准

  • •Presence of sever renal impairment. (Creatinine clearance < 30 ml/min or patient on hemodialysis).
  • •Sever congestive heart failure (NHYA III or IV).
  • •Pregnant woman.
  • •History of bowel obstruction or resection.
  • •Known allergies to polyethylene glycol.
  • •Refusal of consent for the study.
  • •Signs of liver cell failure as ascites and hepatic encephalopathy.
  • •Electrolytes disturbances

研究组 & 干预措施

Split-dose bowel preparation

Experimental

About 90 participants underwent Split-dose bowel preparation for colonoscopy

干预措施: Bowel preparation (Procedure)

single-dose bowel preparation

Experimental

About 90 participants underwent single-dose bowel preparation for colonoscopy

干预措施: Bowel preparation (Procedure)

结局指标

主要结局

colon cleansing

时间窗: 2 hours before Bowel Preparation

to compare the efficacy of split-dose versus single morning administration of PEG solution for colon cleansing in patient undergoing colonoscopy using Boston Bowel Preparation Scale , and to assess the optimal preparation- to-colonoscopy (PC) interval .

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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