跳至主要内容
临床试验/NCT01627171
NCT01627171Unknown4 期

A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
126
试验地点
1
主要终点
Ottawa Bowel Prep Score

研究概览

简要总结

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.

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 (Investigator)

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

  • Inpatient colonoscopy
  • Age greater than 18 years old
  • Able to give consent

排除标准

  • No consent obtained
  • Pregnancy or lactating
  • Renal impairment
  • Severe CHF (NYHA class 3/4)
  • Recent myocardial infarction (preceding 6 months)
  • Severe Colitis
  • Toxic Megacolon
  • Gastrointestinal Obstruction
  • Previous large bowel resection
  • Allergy to study drug

研究组 & 干预措施

PEG Lyte

Active Comparator

PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.

干预措施: Bisacodyl 10mg (Drug)

PEG Lyte

Active Comparator

PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.

干预措施: Polyethelene Glycol (Drug)

Pico Salax Split

Experimental

Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.

干预措施: Bisacodyl 10mg (Drug)

Pico Salax Split

Experimental

Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.

干预措施: Picosulfate sodium (Drug)

Pico Salax Night Before

Experimental

2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

干预措施: Bisacodyl 10mg (Drug)

Pico Salax Night Before

Experimental

2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy

干预措施: Picosulfate sodium (Drug)

结局指标

主要结局

Ottawa Bowel Prep Score

时间窗: 30 minutes after procedure

Using a standardized, validated score for measuring quality of bowel preparation

次要结局

  • Procedures Cancelled or repeated due to inadequate bowel preparation(During admission (average of 2 weeks))
  • Individual Components of Ottawa Bowel Prep Score(30 minutes after procedure)
  • Adverse Effects(Up to 48 hours after procedure)
  • Tolerability of the preparation(Within 1 day of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khurram Khan

Assistant Professor of Medicine

St. Joseph's Healthcare Hamilton

研究点 (1)

Loading locations...

相似试验