Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Score (BBPS)
研究概览
简要总结
4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient.
The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.
详细描述
This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.
Participants with out patient colonoscopy arranged will be included and randomized in a 1:1 ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep® plus 2 sachets SPMC (Picoprep®).
Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse effect by filling the questionnaire before the colonoscopy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient who mentally capable to consent for participating the trial
- •18 - 65 years old
- •Scheduled for 1st colonoscopy
- •Elective outpatient colonoscopy
排除标准
- •Prior colorectal or abdominal-pelvic surgery
- •Inflammatory bowel disease
- •Active bowel condition eg intestinal obstruction
- •Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome
- •Recent myocardial infarction, congestive heart failure, uncontrolled hypertension
- •Renal dysfunction, hepatic disease
- •Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents
- •Hypersensitivity to PEG or SPMC solution
- •Pregnant or breastfeeding women
- •Inability to give informed consent
研究组 & 干预措施
4L Klean Prep®
Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g
干预措施: 4L Klean Prep® (Drug)
1L Klean prep® and 2 sachets Picoprep®
Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g
干预措施: 1L Klean prep® and 2 sachets Picoprep® (Drug)
结局指标
主要结局
Boston Bowel Preparation Score (BBPS)
时间窗: Up to 24 weeks
Adequate bowel preparation is defined as a total BPPS score \>/= 6 in which all three segments had score \>/=2
次要结局
- Patient tolerability to bowel preparation using Likert scale(Up to 24 weeks)
- Patient compliance towards bowel preparation(Till the day of procedure)
- Proportion of patient requiring repeat colonoscopy(Up to 24 weeks)
- Incidence of treatment related adverse events(Up to 24 weeks)
研究者
Tso Yau Kan
Resident
Queen Elizabeth Hospital, Hong Kong