A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients
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
- 否
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
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
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
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
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
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
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
Khurram Khan
Assistant Professor of Medicine
St. Joseph's Healthcare Hamilton
