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Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: a randomised non-inferiority trial.

ABSTRACT: To test the hypothesis that the use of a low-residue breakfast (LRB) the day prior to colonoscopy was not inferior to consuming clear fluids alone (CFD) in patients undergoing outpatient colonoscopy with a polyethylene glycol (PEG) bowel preparation.Optimal colon cleansing is essential for complete visualisation of the mucosa during colonoscopy. Few studies have examined the effect of diet on the quality of bowel cleansing or tolerance in patients using a PEG bowel preparation for colonoscopy.Randomised, single-blinded non-inferiority trial. Adult patients scheduled for outpatient colonoscopy with PEG solution were randomised to an LRB followed by clear fluids or CFD using either a traditional or split-dose PEG solution for bowel preparation. The primary outcome was colon cleansing based on the Ottawa Bowel Preparation Score (OBPS).On an intention-to-treat (ITT) basis, a total of 109 and 105 patients were included in the CFD and LRB arms, respectively, with 116 and 98 patients, respectively, for the per-protocol (PP) analysis. Although there was no difference in the mean total OBPS between the CFD or LRB arms in either the ITT or PP analysis, the threshold for non-inferiority was not met. Patient acceptance of the regimens was higher in the LRB arm than in the CFD arm in the ITT and PP analyses.This study failed to show the non-inferiority of an LRB in patients receiving bowel preparation with a PEG-based solution. A CFD should be prescribed when using a PEG bowel preparation.This trial is registered at ClinicalTrials.gov (NCT01454388).

SUBMITTER: Flemming JA

PROVIDER: S-EPMC4599153 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: a randomised non-inferiority trial.

Flemming Jennifer A JA Green Jordan J Melicharkova Andrea A Vanner Stephen S Hookey Lawrence L

BMJ open gastroenterology 20150528 1

<h4>Goals</h4>To test the hypothesis that the use of a low-residue breakfast (LRB) the day prior to colonoscopy was not inferior to consuming clear fluids alone (CFD) in patients undergoing outpatient colonoscopy with a polyethylene glycol (PEG) bowel preparation.<h4>Background</h4>Optimal colon cleansing is essential for complete visualisation of the mucosa during colonoscopy. Few studies have examined the effect of diet on the quality of bowel cleansing or tolerance in patients using a PEG bow ...[more]

PMID: 26462280

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Project description:AimTo compare same-day whole-dose vs split-dose of 2-litre polyethylene glycol electrolyte lavage solution (PEG-ELS) plus bisacodyl for colon cleansing for morning colonoscopy.MethodsConsecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e., same-day whole-dose or split-dose of 2-litre PEG-ELS. Investigators and endoscopists were blinded to the allocation. All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used. In addition, patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation. Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale (BBPS). In addition, endoscopists gave an overall grading of the quality of bowel preparation. Cecal intubation time, withdrawal time, total colonoscopy time, adenoma detection rate and number of adenomas detected for each patient were recorded. Sample size was calculated using an online calculator for binary outcome non-inferiority trial. Analyses was based upon intent-to-treat. Significance was assumed at P-value < 0.05.ResultsData for 295 patients were analysed. Mean age was 62.0 ± 14.4 years old and consisted of 50.2 % male. There were 143 and 152 patients in the split-dose and whole-dose group, respectively. Split-dose was as good as whole-dose for quality of bowel preparation. The total BBPS score was as good in the split-dose group compared to the whole-dose group [6 (6-8) vs 6 (6-7), P = 0.038]. There was no difference in cecal intubation rate, cecal intubation time, withdrawal time, total colonoscopy time and adenoma detection rate. Median number of adenoma detected was marginally higher in the split-dose group [2 (1-3) vs 1 (1-2), P = 0.010]. Patients in the whole-dose group had more nausea (37.5% vs 25.2%, P = 0.023) and vomiting (16.4% vs 8.4%, P = 0.037), and were less likely to complete the bowel preparation (94.1% vs 99.3%, P = 0.020). Patients in the split-dose group were less likely to refuse the same bowel preparation regime (6.3% vs 13.8%, P = 0.033) and less likely to want to try another bowel preparation regime (53.8% vs 78.9%, P < 0.001).ConclusionSplitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients.

Dataset Information

Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: a randomised non-inferiority trial.

Publications

Low-residue breakfast during the preparation for colonoscopy using a polyethylene glycol electrolyte solution: a randomised non-inferiority trial.

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