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临床试验/NCT01624454
NCT01624454已完成不适用

Osmotic or Large Volume Lavage for Optimal Bowel Preparation - a Single-blind Randomized Trial

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
380
试验地点
2
主要终点
Bowel cleansing quality

研究概览

简要总结

Comparison between large volume and osmotic agent lavage for optimal colonoscopy bowel cleansing, randomizing adult outpatients by invitation letter

详细描述

This randomized quality assurance trial aims to compare cleansing quality of two different principles of colonoscopy lavage. Large volume PEG solutions are considered safe, but cumbersome and inpalatable, while osmotic solutions are generally more acceptable, however, the risk of electrolyte disturbances or renal decompensation may increase.

The study will focus on patient experience and compliance, as well as cleansing quality, endoscopic findings and other technical parameters of the colonoscopy procedure that may be adversely affected by poor bowel cleansing. Three centers will participate, ensuring a diverse patient population. 800 patients are planned for recruitment, but an interim assessment of statistics of the primary aim parameter (bowel cleansing) will be performed to adjust the number.

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 (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pts for out-patient colonoscopy
  • age 18-80

排除标准

  • Active colitis or suspicion thereof (bloody diarrhea, fever and abdominal pain)
  • Suspicion of renal insufficiency or ileus/subileus
  • Previous colonic surgery
  • Pregnancy
  • Inability to adhere to cleansing instructions
  • Inability to consent

结局指标

主要结局

Bowel cleansing quality

时间窗: 1 Day

次要结局

  • Colonoscopy findings(1 Day)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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