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临床试验/NCT00687830
NCT00687830已完成3 期

A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy

Cleveland Clinic Florida1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2008年2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
入组人数
136
试验地点
1
主要终点
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.

研究概览

简要总结

The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.

详细描述

Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.

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

性别
All
接受健康志愿者

入选标准

  • All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.

排除标准

  • Colonoscopy is contraindicated
  • Prior Colectomy or colon surgery.

研究组 & 干预措施

Polythylene Glycol (PEG) in the evening

Active Comparator

Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy.

'Polyethylene Glycol afternoon'

干预措施: Polyethylene Glycol afternoon (Drug)

Polythylene Glycol (PEG) in the Morning

Experimental

Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy.

'Polyethylene Glycol morning'

干预措施: Polyethylene Glycol morning (Drug)

结局指标

主要结局

Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.

时间窗: Within 1 hr after the colonoscopy procedure

次要结局

  • Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.(An hour before the colonoscopy procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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