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
ARTICLE HIGHLIGHTS
Research background

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

Research motivation

Reducing water intake to 2 L can improve comfort, while following a low-residue diet and using lactulose as an adjuvant can enhance the effectiveness of bowel preparation. Therefore, we proposed a bowel preparation regimen involving a mixture of 2 L water with PEG and lactulose along with a low-residue diet for hospitalized patients ≥ 50 years in age who were undergoing colonoscopy.

Research objectives

This study aimed to evaluate the effectiveness, comfort, and safety of a 2-L PEG + 30-mL lactulose + low-residue diet regimen.

Research methods

Non-inferiority analysis was employed to determine whether the efficacy of the regimen of 2-L PEG + 30-mL lactulose + a low-residue diet was not inferior to that of the 4-L PEG regimen. The analysis was performed using intention-to-treat and per-protocol approaches. The primary outcome was to compare the percentage of adequate bowel preparation in each bowel segment and the whole colon in group 1 with that in group 2 as well as to compare the mean Boston bowel preparation scale scores in each bowel segment and the whole colon between the two groups. The secondary outcome was to compare the difference in the comfort and safety of bowel preparation between group 1 and group 2. The comfort assessment included comfort score, sleep duration on the night before colonoscopy, number of awakenings during sleep on the night before colonoscopy, and the presence of bowel incontinence during bowel preparation. Safety assessment included laboratory test results of serum potassium, sodium, calcium, and creatinine and plasma B-type brain natriuretic peptide before and after bowel preparation.

Research results

The bowel preparation regimen comprising a low dose of 2-L PEG + 30-mL lactulose + a low-residue diet had a good bowel preparation effect along with comfort and safety profiles for patients ≥ 50 years in age. Furthermore, in the subgroup of patients ≥ 75 years in age who were at higher risk of inadequate bowel preparation, the 2-L PEG + 30-mL lactulose + a low-residue diet regime was not inferior to the 4-L PEG regimen.

Research conclusions

In 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 that yielded by the 4-L PEG regimen and even provided better comfort.

Research perspectives

Patients ≥ 50 years in age require long-term and regular colonoscopies due to their notably higher CRC morbidity and mortality. The bowel preparation regimen of 2-L PEG + 30-mL lactulose + a low-residue diet is comparable with the high-dose (4 L) PEG regimen for bowel cleansing and even provides better comfort. These study results may contribute to supporting and improving decision-making in clinical practice.