Comparative Evaluation of the Efficacy of Oral Sulfate Solution (OSS) and 2L Polyethylene Glycol (PEG) With Ascorbic Acid (Asc) for Bowel Preparation of Elderly People: A Multicenter Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS)
研究概览
简要总结
For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).
详细描述
This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.
The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.
99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.
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)
盲法说明
Single Blind (Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonoscopy examinee aged 65-80
- •Examinee agree with informed consent
排除标准
- •Cognitive disorder, mental retardation
- •Bowel obstruction
- •Severe constipation (<3 bowel movements per week with or without regular or intermittent laxatives)
- •History of bowel surgery
- •Liver cirrhosis or ascites
- •Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
- •Inflammatory bowel disease
- •Pregnancy, lactating woman
- •Renal impairment or history of impaired renal function
- •History of hypersensitivity reaction to bowel preparation
研究组 & 干预措施
Oral sulfate solution (OSS) taking group
On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water.
干预措施: Oral sulfate solution (OSS) (Drug)
2L PEG/Asc taking group
On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.
干预措施: 2L PEG/Asc (Drug)
结局指标
主要结局
Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS)
时间窗: 3 months
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
- Taste of recommended bowel preparation agent based on the 5-grade scale(3 months)
- Number of subjects who have a willingness to repeat the same regimen(3 months)
- Rate of subjects with nausea(3 months)
- Rate of subjects with vomiting(3 months)
- Rate of subjects with abdominal pain(3 months)
- Rate of subjects with abdominal distention(3 months)
- Rate of subjects with thirst(3 months)
- Rate of subjects with dizziness(3 months)
- Rate of subjects with paresthesia(3 months)
- Subject's satisfaction based on the 10-point visual analog scale(3 months)
- Number of subjects who have a difficulty taking solution based on the 5-grade scale(3 months)
- Chloride level in mmol/L(3 months)
- Sodium level in mmol/L(an average of 1 year)
- Potassium level in mmol/L(3 months)
- Magnesium level in mg/dL(3 months)
- Phosphorus level in mg/dL(3 months)
- Calcium level in mg/dL(3 months)
- Blood urea nitrogen level in mg/dL(3 months)
- Creatinine level in mg/dL(3 months)
- Serum osmolarity in mmol/kg(3 months)
- Urine osmolarity in mmol/L(3 months)