Optimal Bowel Preparation Regimen for Patients With With a History of Colorectal Resection Before Colonoscopy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Difference of scores rating by Aronchick Preparation Scale among 3 groups.
研究概览
简要总结
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L PEG-ELS) and high-volume preparation (4 L PEG-ELS) in patients with previous colorectal resection.
详细描述
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost. A history of colorectal resection represents an independent predictor for inadequate colon cleansing,hence strategies to improve bowel preparation may be a demanding goal in this subset of patients.
The study compares the efficacy of bowel cleansing between the standard preparation (2 L polyethylene glycol electrolyte solution, 2 L PEG-ELS), low-volume preparation (10 mg bisacodyl plus 2 L polyethylene glycol electrolyte solution) and high-volume preparation (4L polyethylene glycol electrolyte solution, 4L PEG-ELS) in patients with previous colorectal resection. Then the investigators can select the optimized regimen for patients with colorectal surgery.
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
- Single (Investigator)
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
- 否
入选标准
- •All adults (18< age<75years) referred for surveillance colonoscopy with a history of colorectal resection for Colorectal cancer (CRC).
排除标准
- •severe comorbidities (e.g. congestive heart failure and severe kidney disease)
- •abdominal and pelvic surgery other than colorectal resection for the cause of CRC.
- •severe colonic stricture or obstructing tumour
- •dysphagia
- •compromised swallowing reflex or mental status
- •significant gastroparesis or gastric outlet obstruction
- •known or suspected bowel obstruction or perforation
- •severe chronic renal failure (creatinine clearance<30 ml/min
- •severe congestive heart failure (New York Heart Association class III or IV)
- •uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •inflammatory bowel disease or megacolon
- •dehydration
- •disturbance of electrolytes
- •pregnancy or lactation
- •haemodynamically unstable
- •unable to give informed consent.
研究组 & 干预措施
GroupA：standard preparation
Subjects who are randomized into group A receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
干预措施: standard preparation (2L PEG-ELS) (Drug)
Group B:low-volume preparation
Subjects who are randomized into group B receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure. ( 2L PEG-ELS and 10mg bisacodyl )
干预措施: low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS) (Drug)
Group C：high-volume preparation
Subjects who are randomized into group C will receive 2L PEG-ELS at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure. (4 L PEG-ELS)
干预措施: high-volume preparation (4L PEG-ELS) (Drug)
结局指标
主要结局
Difference of scores rating by Aronchick Preparation Scale among 3 groups.
时间窗: 6 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared among the 3 groups.
次要结局
- Rate of compliance with instructions among 3 groups(6 months)
- Withdrawal time among 3 groups.(6 months)
- Caecal intubation rate among 3 groups.(6 months)
- Willingness to repeat bowel preparation among 3 groups.(6 months)
- Polyp detection rate among 3 groups.(6 months)
研究者
Yanqing Li
PhD, MD
Shandong University