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Clinical Trials/KCT0006149
KCT0006149
Completed
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 sites184 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of the digestive system
Sponsor
Asan Medical Center
Enrollment
184
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
who.int
Start Date
TBD
End Date
July 26, 2022
Last Updated
last year
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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