Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Aronchick Scale Bowel Cleaning Scale
研究概览
简要总结
The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.
详细描述
Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.
This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 20 and 99 years, inclusive.
- •Men or non-pregnant women who are scheduled for an elective colonoscopy.
- •Subjects should be willing, able to complete the entire procedure and to comply with study instructions.
- •Written informed consent obtained prior to study.
排除标准
- •Patients who are not suitable for colonoscopy
- •Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
- •Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- •Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo- obstruction, hypomotility syndrome)
- •Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
- •Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or uncontrolled hypertension
- •Renal insufficiency
- •Any prior colorectal surgery
- •in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
- •History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- •Severe chronic constipation
- •Hypersensitivity to any ingredient in the study medication
研究组 & 干预措施
split dose, day before, colonoscopy in the morning (Observation Group)
routine bowel preparation before colonoscopy in the morning
干预措施: Bowklean (Drug)
split dose, day before, colonoscopy in the afternoon (Random)
routine bowel preparation before colonoscopy in the afternoon
干预措施: Bowklean (Drug)
two dose in the same day, colonoscopy in the afternoon (Random)
experimental group
干预措施: Bowklean (Drug)
结局指标
主要结局
Aronchick Scale Bowel Cleaning Scale
时间窗: during colonoscopy
Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed
次要结局
- Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale(During Colonoscopy)
- Colonscopy Bubble Scale(During Colonoscopy)
研究者
HSUHENG YEN
Head of Endoscopy Room
Changhua Christian Hospital