Bowel Preparation With Standard 4 Liters of PEG vs. Split-dose of 4 Liters PEG vs. Split-dose of 2 Liters PEG Containing Ascorbic Acid Solutions for Outpatient Elective Colonoscopy in the Elderly: A Randomized, Colonoscopist-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS).
研究概览
简要总结
The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people.
The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume [2L] PEG-3350 containing ascorbic acid solution.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elderly people aged over 65 years
- •elective outpatient colonoscopy
- •informed consent
排除标准
- •patients who had bowel movements of less than 3 per week during last one month
- •patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance)
- •patients who have a history of alimentary tract surgery
- •patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis)
- •patients classified as the American Society for Anesthesiology class III or higher
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
研究组 & 干预措施
Standard full-volume PEG
干预措施: Standard full-volume PEG (Drug)
Split-dose full-volume PEG
干预措施: Split-dose full-volume PEG (Drug)
Split-dose low-volume PEG
干预措施: Split-dose low-volume PEG (Drug)
结局指标
主要结局
Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS).
时间窗: 1 year
The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment.
次要结局
- Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale(1 year)
- Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale(1 year)
- Rate of adverse events related to bowel preparation for colonoscopy(1 year)
- Number of patients who have a willingness to repeat same bowel preparation method method(1 year)
- Consumed volume of recommended bowel preparation agent based on the 3-grade scale(1 year)
- Taste of recommended bowel preparation agent based on the 3-grade scale(1 year)
研究者
Chang Kyun Lee
Associate professor
Kyunghee University Medical Center