The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Quality of bowel preparation
研究概览
简要总结
Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy
排除标准
- •known hypersensitivity to polyethylene glycol
- •severe congestive heart failure [New York Heart Association (NYHA) grade III or grade IV]
- •severe renal insufficiency (creatinine clearance <30 ml/min)
- •hemodynamic instability
- •suspected intestinal obstruction or perforation
- •compromised swallowing reflex or altered mental status
- •pregnancy or lactating woman
- •patients who declined to participate
研究组 & 干预措施
Additional oral preparation
The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy.
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
干预措施: Additional oral preparation (3L of PEG+Asc, "Coolprep®") (Drug)
Standard oral preparation
The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy.
* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
干预措施: Standard oral preparation (2L of PEG+Asc, "Coolprep®") (Drug)
结局指标
主要结局
Quality of bowel preparation
时间窗: Day 1
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
次要结局
- Adenoma detection rate(Day 1)
- Patient satisfaction(Baseline)
- Patient compliance(Baseline)
研究者
Eun Soo Kim, MD, PhD
Professor
Kyungpook National University Hospital