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临床试验/NCT03242369
NCT03242369Unknown不适用

Comparison of the Effectiveness of Bowel Preparations in Bowel Cleansing Before Colonoscopy - Prospective, Randomized Study

Military University Hospital, Prague2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
2
主要终点
Quality of bowel cleansing according to Boston Bowel Preparation Scale (BBPS)

研究概览

简要总结

Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could be suitable substitution of polyethylene glycol.

详细描述

This study will be unicenter, randomized and single blind. It focuses on studying the effectiveness of four preparations for bowel cleansing before colonoscopy. Polyethylenglycol (PEG) will be compared as a gold standard of bowel cleansing with low volume preparations: Sulfate-based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium citric-acid and sodium picosulfate. The effectiveness will be rated according to a quality of bowel preparation (Boston Bowel Preparation Scale) and detection of a colorectal neoplasia. The aim of this project is to compare the effectiveness of each four preparations.

Primary endpoint: To compare a quality of bowel preparation. Secondary endpoint: To compare a detection of colorectal neoplasia in those preparations.

Main hypothesis: PEG as a gold standard of bowel cleansing preparation is not worse than the other compared preparations.

Secondary hypothesis: PEG is not worse in detection of colorectal neoplasia than the other compared preparations.

Methods: There will be 400 patients included in the project with all indications for colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. The patients will be offered to participate in the study at the Endoscopy unit when arranging the examination. In case of agreement they will sign informed consent and they will be educated about the correct process of bowel preparation. They also get all the instructions in printed version and questionnaire of preparation tolerability. The advantages for the patients in study will be earlier date of colonoscopy. On the day of colonoscopy, the patients will submit the questionnaire and undergo standard colonoscopy examination.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuls ≥ 18 years old undergoing colonoscopy for all indications except

排除标准

  • Exclusion Criteria:
  • Active idiopathic bowel disease
  • Chronic renal insufficiency
  • Serious internal comorbidity
  • Planned therapeutic colonoscopy
  • No informed consent signed (with the study and/or with the colonoscopy)

研究组 & 干预措施

PEG group

Experimental

100 patients undergoing colonoscopy.

干预措施: colonoscopy (Procedure)

SBS group

Experimental

100 patients undergoing colonoscopy

干预措施: colonoscopy (Procedure)

PEG 2L + ascorbic acid group

Experimental

100 patients undergoing colonoscopy.

干预措施: colonoscopy (Procedure)

PICO group

Experimental

100 patients undergoing colonoscopy.

干预措施: colonoscopy (Procedure)

结局指标

主要结局

Quality of bowel cleansing according to Boston Bowel Preparation Scale (BBPS)

时间窗: 1 day

* 0-Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared * 1-Portion of mucosa of the colon segment seen, but other areas of the segment are not well seen due to staining, residual stool, and/or opaque liquid * 2-Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa colon segment is seen well * 3-Entire mucosa of colon segment seen well, with no residual staining, small fragment of stool or opaque liquid

次要结局

  • Detection of colorectal neoplasia(1 day)

研究者

发起方
Military University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stepan Suchanek, MD., Ph.D.

Head of Department of Gastrointestinal Endoscopy

Military University Hospital, Prague

研究点 (2)

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