跳至主要内容
临床试验/NCT01685853
NCT01685853已完成3 期

Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.

European Institute of Oncology1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
164
试验地点
1
主要终点
Efficacy

研究概览

简要总结

The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

详细描述

Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Out-patients undergoing a complete colonoscopy
  • Patient written informed consent

排除标准

  • Pregnant or lactating women or at a risk of becoming pregnant
  • Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients

研究组 & 干预措施

PEG 4 litres split

Active Comparator

Polyethylene glycol with electrolytes (PEG)

干预措施: PEG 4 litres split (Drug)

Bisacodyl plus PEG-CS

Experimental

Bisacodyl plus PEG-CS: Bisacodyl plus Polyethylene glycol with citrate and simethicone (PEG-CS)

干预措施: Bisacodyl plus PEG-CS (Drug)

结局指标

主要结局

Efficacy

时间窗: 20 min

Evaluation of the quality of bowel preparation according to the Ottawa Scale

次要结局

  • Efficacy(20 min)
  • Safety(24 hours)
  • Tolerability(24 hours)
  • Acceptability(24 hours)
  • Compliance(24 hours)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Bowel Cleansing for Colonoscopy: Comparison Between... | 临床试验