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临床试验/KCT0000708
KCT0000708已完成未知

Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopy

Seoul National University Hospital0 个研究点目标入组 187 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
187

研究概览

简要总结

BACKGROUND: Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution. METHODS: This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered. RESULTS: A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01). CONCLUSIONS: Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution. TRIAL REGISTRATION: ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
20(Year) 至 75(Year)(—)
性别
All

入选标准

  • (1)willing to consent/undergo necessary procedures
  • (2)between the age of 20 and 75 years
  • (3)healthy persons planning to have a colonoscopy

排除标准

  • (1)history of abdominal surgery except appendectomy
  • (2)inflammatory bowel disease
  • (3)clinically or laboratory-confirmed ileus (both functional and mechanical)
  • (4)malignancy
  • (5)clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
  • (6)dementia, cognitive impairment
  • (7)the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
  • (8)known sensitivity to the agents used
  • (9)Pregnancy, Lactating woman

研究者

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