A Randomized Controlled Trial Examining Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose Polyethylene Glycol
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Patient tolerability
研究概览
简要总结
Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy
排除标准
- •ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (<6 months) myocardial infarction or unstable angina
研究组 & 干预措施
Split dose PEG
Patients randomized to the Polyethylene Glycol (PEG) group will be instructed to ingest 2L of bowel preparation the night before their colonoscopy (starting at 7PM), as well as 1.5-2L of carbohydrate-electrolyte rehydration solution. The following day they will be instructed to ingest the remaining 2L of bowel preparation and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy.
干预措施: Polyethylene Glycol (Drug)
Split dose Picosalax
Patients randomized to the Picosalax (P/MC) group will be instructed to mix one sachet in 150mL of water and ingest the entire mixture at 7PM the night before their colonoscopy. In addition, they will be instructed to ingest 1.5-2L of carbohydrate-electrolyte rehydration solution after they consume the P/MC sachet. The following day they will mix the second sachet in 150mL of water and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. They will also be instructed to drink additional carbohydrate-electrolyte rehydration solution after they ingest the P/MC sachet.
干预措施: Picosalax (Drug)
结局指标
主要结局
Patient tolerability
时间窗: Two days
Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure
次要结局
- Quality of bowel preparation(During colonoscopy)
研究者
Dr. Lawrence Hookey
Principal Investigator
Queen's University