Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jan 16, 2024; 16(1): 18-28
Published online Jan 16, 2024. doi: 10.4253/wjge.v16.i1.18
Bowel preparation protocol for hospitalized patients ages 50 years or older: A randomized controlled trial
Yu He, Qi Liu, Yi-Wen Chen, Li-Jian Cui, Kai Cao, Zi-Hao Guo
Yu He, Qi Liu, Yi-Wen Chen, Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
Li-Jian Cui, Zi-Hao Guo, Department of Gastroenterology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
Kai Cao, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
Author contributions: Liu Q, Chen YW, and He Y designed the study; He Y, Cui LJ, and Guo ZH conducted the study; He Y and Cui LJ collected the data; He Y, Chen YW, Cao K, and Liu Q analyzed the data; He Y and Chen YW drafted the manuscript.
Institutional review board statement: The study was approved by the Ethics Committee of Beijing Tongren Hospital Affiliated to Capital Medical University (Approval No. TRECKY2021-227).
Clinical trial registration statement: This study is registered at ClinicalTrials.gov, registration number NCT05397158 (https://clinicaltrials.gov/ct2/show/NCT05397158).
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript having no conflicts of interest to disclose.
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 that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qi Liu, MD, PhD, Chief Physician, Professor, Department of Geriatrics, Beijing Tongren Hospital, Capital Medical University, No. 1 Dongjiaominxiang Street, Dongcheng District, Beijing 100730, China. liuqi6612@mail.ccmu.edu.cn
Received: August 26, 2023
Peer-review started: August 26, 2023
First decision: November 20, 2023
Revised: December 2, 2023
Accepted: December 14, 2023
Article in press: December 14, 2023
Published online: January 16, 2024
Processing time: 141 Days and 17.3 Hours
Abstract
BACKGROUND

The incidence and mortality rate of colorectal cancer progressively increase with age and become particularly prominent after the age of 50 years. Therefore, the population that is ≥ 50 years in age requires long-term and regular colonoscopies. Uncomfortable bowel preparation is the main reason preventing patients from undergoing regular colonoscopies. The standard bowel preparation regimen of 4-L polyethylene glycol (PEG) is effective but poorly tolerated.

AIM

To investigate an effective and comfortable bowel preparation regimen for hospitalized patients ≥ 50 years in age.

METHODS

Patients were randomly assigned to group 1 (2-L PEG + 30-mL lactulose + a low-residue diet) or group 2 (4-L PEG). Adequate bowel preparation was defined as a Boston bowel preparation scale (BBPS) score of ≥ 6, with a score of ≥ 2 for each segment. Non-inferiority was prespecified with a margin of 10%. Additionally, the degree of comfort was assessed based on the comfort questionnaire.

RESULTS

The proportion of patients with a BBPS score of ≥ 6 in group 1 was not significantly different from that in group 2, as demonstrated by intention-to-treat (91.2% vs 91.0%, P = 0.953) and per-protocol (91.8% vs 91.0%, P = 0.802) analyses. Furthermore, in patients ≥ 75 years in age, the proportion of BBPS scores of ≥ 6 in group 1 was not significantly different from that in group 2 (90.9% vs 97.0%, P = 0.716). Group 1 had higher comfort scores (8.85 ± 1.162 vs 7.59 ± 1.735, P < 0.001), longer sleep duration (6.86 ± 1.204 h vs 5.80 ± 1.730 h, P < 0.001), and fewer awakenings (1.42 ± 1.183 vs 2.04 ± 1.835, P = 0.026) than group 2.

CONCLUSION

For hospitalized patients ≥ 50 years in age, the bowel preparation regimen comprising 2-L PEG + 30-mL lactulose + a low-residue diet produced a cleanse that was as effective as the 4-L PEG regimen and even provided better comfort.

Keywords: Aged 50 years or older; Hospitalized; 2-L polyethylene-glycol + 30-mL lactulose + a low-residue diet; Comfort

Core Tip: Individuals ≥ 50 years in age require long-term and regular colonoscopies. Uncomfortable bowel preparation is the main reason preventing patients from undergoing regular colonoscopies. The 4-L polyethylene glycol (PEG) regimen is effective but poorly tolerated. We observed that the 2-L PEG + 30-mL lactulose + low-residue diet regimen was not inferior to the 4-L PEG regimen. The 2-L PEG + 30-mL lactulose + low-residue diet regimen was more comfortable than the 4-L PEG regimen. In patients ≥ 75 years in age, 2-L PEG + 30-mL lactulose + low-residue diet regimen was still effective.