Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 7, 2021; 27(5): 428-441
Published online Feb 7, 2021. doi: 10.3748/wjg.v27.i5.428
Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit
Shih-Ya Hung, Hung-Chang Chen, Tao-Wei Ke, Jiann-Hwa Chen, Koung-Hung Hsiao, Hwei-Ming Wang, Hua-Che Chiang, Sheng-Chi Chang, Yi-Chang Chen, Ming-Hao Hsieh, Yuan-Yao Tsai, Yo-Wen Hsieh, William Tzu-Liang Chen
Shih-Ya Hung, Graduate Institute of Acupuncture Science, China Medical University, Taichung 40402, Taiwan
Shih-Ya Hung, Department of Medical Research, China Medical University Hospital, Taichung 40447, Taiwan
Hung-Chang Chen, Tao-Wei Ke, Hwei-Ming Wang, Hua-Che Chiang, Sheng-Chi Chang, Yi-Chang Chen, Ming-Hao Hsieh, Yuan-Yao Tsai, Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung 40447, Taiwan
Jiann-Hwa Chen, Division of Gastroenterology, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan
Koung-Hung Hsiao, Division of Colorectal Surgery, Taipei Tzu Chi Hospital, Taipei 23142, Taiwan
Yo-Wen Hsieh, Department of Pharmacy, China Medical University Hospital, Taichung 40447, Taiwan
William Tzu-Liang Chen, Department of Colorectal Surgery, China Medical University Hsinchu Hospital, Zhubei 30272, Taiwan
William Tzu-Liang Chen, School of Medicine, China Medical University, Taichung 40402, Taiwan
Author contributions: Chen WTL and Chen HC worked on conceptualization, methodology, and project administration; Chen WTL and Hung SY worked on original draft preparation and manuscript editing; Chen HC, Ke TW, Chen JH, Hsiao KH, Wang HM, Chiang HC, Chang SC, Chen YC, Hsieh MH, Tsai YY, and Chen WTL performed colonoscopy, data collection, and data curation; Hsieh YW worked on drug dispensing and pharmaceutical care.
Supported by The China Medical University Hospital, No. DMR-108-125.
Institutional review board statement: This study was reviewed and approved by the Institutional Review Boards of China Medical University Hospital (CMUH107-REC2-151) and Taipei Tzu Chi Hospital (08-FS-030). Study methods were conducted in accordance with the Institutional Review Board committee guidelines.
Clinical trial registration statement: This study has been registered at https://clinicaltrials.gov/ct2/show/NCT03992365 (ID: NCT03992365).
Informed consent statement: Written informed consent was provided by all study participants.
Conflict-of-interest statement: Quiklean® was provided by Universal Integrated Corporation (Taiwan). The authors have no conflicts of interest to declare.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: William Tzu-Liang Chen, MD, Superintendent, Department of Colorectal Surgery, China Medical University Hsinchu Hospital, No. 199 Sec. 1, Xinglong Road, Zhubei 30272, Taiwan. wtchen@mail.cmuh.org.tw
Received: November 5, 2020
Peer-review started: November 5, 2020
First decision: December 13, 2020
Revised: December 24, 2020
Accepted: January 6, 2021
Article in press: January 6, 2021
Published online: February 7, 2021
Core Tip

Core Tip: The bowel cleanser 32-tablet sodium phosphate (Quiklean®) is an adequate bowel cleansing preparation with better tolerability and acceptability than the standard comparator 2-L polyethylene glycol/bisacodyl (Klean-Prep/Dulcolax®).