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临床试验/NCT05397158
NCT05397158已完成不适用

Study on Optimization of Intestinal Preparation Before Colonoscopy in Older Patients

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
312
试验地点
1
主要终点
Intestinal preparation Cleanliness assessment

研究概览

简要总结

Older adults are susceptible to intestinal tumors. Colonoscopy can screen colorectal cancer, adenoma and other diseases. There is a large demand for colonoscopy in the older adults, and the risk during peri-colonoscopy period is high. According to the common intestinal preparation methods and the characteristics of the older adults, the investigators propose a modified method, that is single administration of low dose polyethylene glycol (PEG). Specifically, take 30ml lactulose in the morning 1 day before the examination, and eat without residue in lunch and dinner, Take 2L PEG in the morning of the examination day and fast at breakfast and lunch of the day. Taking 4L PEG in 2 days as the control group. The fasting and diarrhea period is shorter in the modified group than that in the control group, and the dose of PEG is less. Lactulose, a laxative, is taken one day before the examination, and the intestinal preparation time is longer than that of single administration. The situation of comfort, sleep and fecal incontinence during the intestinal preparation of the two groups will be compared. The results of electrolyte, blood glucose and B-type brain natriuretic peptide between the two groups will be also compared. The effect of intestinal preparation will be evaluated by the standardization of Boston intestinal preparation scale, and endoscopist blind method will be used in colonoscopy.

详细描述

The participants in control group take 2L PEG the day before the examination, fast at dinner (participants without diabetes) and eat without residue (participants with diabetes). Participants take 2L PEG again in the morning of the examination day, and fasted at breakfast and lunch of the day.

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)

盲法说明

Endoscopist blind method.

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colonoscopy is planned
  • Willing to participate

排除标准

  • Unwilling to participate
  • Missing data

结局指标

主要结局

Intestinal preparation Cleanliness assessment

时间窗: Up to 1 hour

The effect of intestinal preparation will be evaluated by Boston Intestinal Preparation Scale.The minimum score is 0,and the maximum score is 9. Higher scores mean a better outcome. Endoscopist blind method will be used.

次要结局

  • The situation of fecal incontinence during the intestinal preparation(One day)
  • Blood potassium level before and after intestinal preparation(Up to 1 week)
  • Blood glucose level before and after intestinal preparation(Up to 1 week)
  • B-type brain natriuretic peptide (BNP) level before and after intestinal preparation(Up to 1 week)
  • The situation of comfort during the intestinal preparation(Two days)
  • Blood sodium level before and after intestinal preparation(Up to 1 week)
  • The situation of sleep during the intestinal preparation(One day)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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