Randomized Clinical Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 28, 2017; 23(32): 5986-5993
Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5986
Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation
Jae Hyuck Jun, Koon Hee Han, Jong Kyu Park, Hyun Il Seo, Young Don Kim, Sang Jin Lee, Baek Gyu Jun, Min Sik Hwang, Yoon Kyoo Park, Myeong Jong Kim, Gab Jin Cheon
Jae Hyuck Jun, Koon Hee Han, Jong Kyu Park, Hyun Il Seo, Young Don Kim, Sang Jin Lee, Baek Gyu Jun, Min Sik Hwang, Yoon Kyoo Park, Gab Jin Cheon, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung 25440, South Korea
Myeong Jong Kim, Catholic Kwandong University, Gangneung 25440, South Korea
Author contributions: Jun JH planned the study protocol and main write up of the article; Han KH helped in write up of article and screening of patients; Han KH and Seo HI performed majority of colonoscopy; Park JK, Kim YD, Lee SJ, Jun BG, Hwang MS, Park YK, and Cheon GJ were responsible for patient enrollment, screening and manuscript drafting; Kim MJ contributed to data analysis and interpretation; all the authors reviewed and approved the final version to be published.
Institutional review board statement: The study was reviewed and approved by the Gangneung Asan Hospital Institutional Review Board.
Clinical trial registration statement: This study is registered at [https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=8192&ltype=&rtype=]. The registration identification number is [KCT0002348].
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors claim no conflict of interest.
Data sharing statement: No additional data are available.
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/
Correspondence to: Koon Hee Han, Associate professor, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, 38 Bangdong-gil, Sacheon-myeon, Gangneungsi 25440, South Korea. 9292@gnah.co.kr
Telephone: +82-33-6103139 Fax: +82-33-6108130
Received: April 12, 2017
Peer-review started: April 12, 2017
First decision: May 16, 2017
Revised: June 10, 2017
Accepted: July 22, 2017
Article in press: July 24, 2017
Published online: August 28, 2017
Processing time: 138 Days and 4.3 Hours
Abstract
AIM

To compare the efficacy of fixed-time split dose and split dose of an oral sodium picosulfate for bowel preparation.

METHODS

This is study was prospective, randomized controlled study performed at a single Institution (2013-058). A total of 204 subjects were assigned to receive one of two sodium picosulfate regimens (i.e., fixed-time split or split) prior to colonoscopy. Main outcome measurements were bowel preparation quality and subject tolerability.

RESULTS

There was no statistical difference between the fixed-time split dose regimen group and the split dose regimen group (Ottawa score mean 2.57 ± 1.91 vs 2.80 ± 2.51, P = 0.457). Cecal intubation time and physician’s satisfaction of inspection were not significantly different between the two groups (P = 0.428, P = 0.489). On subgroup analysis, for afternoon procedures, the fixed-time split dose regimen was equally effective as compared with the split dose regimen (Ottawa score mean 2.56 ± 1.78 vs 2.59 ± 2.27, P = 0.932). There was no difference in tolerability or compliance between the two groups. Nausea was 21.2% in the fixed-time split dose group and 14.3% in the split dose group (P = 0.136). Vomiting was 7.1% and 2.9% (P = 0.164), abdominal discomfort 7.1% and 4.8% (P = 0.484), dizziness 1% and 4.8% (P = 0.113), cold sweating 1% and 0% (P = 0.302) and palpitation 0% and 1% (P = 0.330), respectively. Sleep disturbance was two (2%) patients in the fixed-time split dose group and zero (0%) patient in the split dose preparation (P = 0.143) group.

CONCLUSION

A fixed-time split dose regimen with sodium picosulfate is not inferior to a split dose regimen for bowel preparation and equally effective for afternoon colonoscopy.

Keywords: Colonoscopy; Bowel preparation; Split dose preparation; Sodium picosulfate; Ottawa Bowel Preparation Scale

Core tip: Fixed-time split dose bowel preparation was not inferior to a split dose regimen in bowel cleansing using the Ottawa Bowel Preparation Scale. The average score using the Ottawa Scale was 2.57 ± 1.91 in the fixed-time split dose group and 2.80 ± 2.51 in the split dose group (P = 0.457). There was no statistical difference in mean Ottawa score between the two groups when the procedure was performed in the morning or afternoon (2.56 ± 1.78 vs 2.59 ± 2.27, P = 0.932). Therefore fixed-time split dosing with soduim picosulfate is as effective as split dosing for subjects scheduled for colonoscopy in the afternoon.