Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- The Ottawa Bowel Preparation Scale
研究概览
简要总结
Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation which makes bowel preparation an important issue. Hence, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
详细描述
Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate positive correlation with good bowel preparation. That makes bowel preparation an important issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and safety. However, there are many different adjunctive, dose, timing of administration in PEG preparation. Some may decrease patient tolerability due to large fluid volume, and some may influence patient's life and sleep quality when performing bowel preparation. Here, investigators conduct a clinical trial about adding another laxative agent to morning single dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower life/sleep impact compared with standard regimen.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-70 years.
- •Out-patient department ambulatory patient.
- •Patients who have indications to receive colonoscopy.
排除标准
- •Age is under 20 or over 70
- •Have severe renal impairment (hemodialysis or eGFR<30).
- •Have severe congestive heart failure (NYHAⅢorⅣ).
- •Pregnant or lactating, or women is under oral contraceptive.
- •Have history of bowel obstruction or resection, known or suspected gastroparesis acute gastric/intestinal ulcer, toxic colitis or megacolon
- •Be allergic to polyethylene glycol (PEG) or bisacodyl.
- •Have severe constipation ( ≤ 1 bowel movement per week).
- •Patient who has Phenylketonuria.
- •Refuse to sign consent to the study.
研究组 & 干预措施
Polyethylene glycol and bisacodyl
In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination.
干预措施: Polyethylene glycol and bisacodyl (Drug)
Split-dose polyethylene glycol
The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination .
干预措施: Split-dose polyethylene glycol (Drug)
结局指标
主要结局
The Ottawa Bowel Preparation Scale
时间窗: Within 24 hours after colonoscopy
Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as "good preparation".
次要结局
- Life disturbance(30 minutes before patient receive colonoscopy)