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临床试验/KCT0006149
KCT0006149已完成未知

A comparative study on the effect and preference of Plenvu powd.(Polyethylene Glycol+Ascorbic acid) and ORA-FANG tab.(Oral sulfate solution)

Asan Medical Center0 个研究点目标入组 184 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
184

研究概览

简要总结

Background: Proper bowel preparation during colonoscopy is important because it can affect the diagnostic accuracy of colonoscopy. Various low-capacity intestinal cleansers are being developed to improve the quality of intestinal cleansers and make them more convenient for patients to use. We aimed to check the efficacy and safety of low-dose intestinal cleansers. Methodology: A study conducted in a single center in a positive, random and single-blind manner. Patients who agreed to participate in the study will be randomly assigned to either the Oralsulfate solution (OSS) or 1L polyethyleneglycol (PEG)+ascorbate for the study. Based on the Boston Intestinal Preparation Scale (BBPS), the degree of intestines, patient satisfaction, and side effects were evaluated. Results: 171 patients were eventually analyzed. There was no significant difference (95.4% OSS; 96.4% 1LPEG + ascorbate; p=0.736) in the degree of adequate preparation (BBPS total score =6 and each segment score =2). Satisfaction with drug use was significantly higher in the OSS group (p<0.001), and the frequency of side effects was low in the OSS group (26.4% OSS; 50.0% 1L PEG+ascorbate; p<0.001). Side effects in both groups were minor and recovered without special treatment. Conclusion Both OSS and 1LPEG+ascorbate, which are low-capacity bowel cleaners, are effective in intestinal cleansing and no serious side effects have been reported.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 0No Limit(—)
性别
All

入选标准

  • 1. Patients hospitalized for colonoscopy treatment such as polypectomy
  • 2. Patients who are asymptomatic and visited the gastroenterology department for screening or surveillance colonoscopy for colon cancer screening purposes

排除标准

  • 1. Men or women under the age of 18
  • 2. Patients with chronic bowel disease, including inflammatory bowel disease
  • 3. Patients with massive bloody stool
  • 4. Patients with renal dysfunction (CKD stage IV or higher)
  • 5. Patients for the purpose of follow-up after colon cancer surgery and pret-reatment before colon surgery
  • 6. People with mental retardation or cognitive impairment who are unable to make voluntary decisions
  • 7. When other researchers judge that participation in research is inappropriate

研究者

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