Comparing low volume versus intermediate volume bowel preparation and their impact on work and tolerability: an open-label, noninferiority randomized controlled trial

Bowel preparation is essential for colonoscopy but may deter patients. Although low volume laxatives are better tolerated, their impact on patient-reported outcomes remains unclear. We compared low and intermediate volume bowel preparation and assessed their impact on tolerability, health-related quality of life (HRQoL), and work.We conducted an open-label, noninferiority randomized trial in four Dutch hospitals. Patients were randomized to 2 L polyethylene glycol with ascorbate (2L PEG+Asc) or 1 L with added sodium sulfate (1L PEG+Asc). Before and after preparation, patients completed validated questionnaires on productivity, tolerability, and HRQoL. The primary outcome was the proportion of patients with adequate bowel preparation, aiming to demonstrate noninferiority of 1L PEG+Asc vs. 2L PEG+Asc (5% noninferiority margin). Secondary outcomes included willingness to repeat, with exploratory analysis of associated factors using multivariable logistic regression, change in HRQoL scores, tolerability, and work-related impact.We included 467 patients (2L PEG+Asc, n = 229; 1L PEG+Asc, n = 238). 1L PEG+Asc was noninferior to 2L: adequate cleansing rate, 96.1% (95%CI 92.6% to 98.0%) vs. 96.4% (95%CI 93.0% to 98.3%; <i>P</i> = 0.84; Δ -0.4, 95%CI -4.0 to 3.3). More patients in the 1L PEG+Asc group were willing to repeat the preparation (59.9% vs. 48.3%; <i>P</i> = 0.04), with tolerability the most influential factor (odds ratios 0.05 and 0.22 for difficult or fair vs. good tolerability, adjusted for symptoms, satisfaction, and 1L/2L PEG+Asc). No clinically relevant changes in HRQoL were observed. Absenteeism and impaired work productivity occurred in 7.9% and 12.3%, respectively, with no between-group differences.Bowel preparation with 1L PEG+Asc is noninferior to 2L PEG+Asc and associated with higher willingness to repeat. Tolerability is fundamental for effective cleansing and reducing colonoscopy barriers.

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Publication Details

Journal
Endoscopy
Published
2025-09-03
DOI
https://doi.org/10.1055/a-2695-0994
Citations
2
Primary Topic
Nutrition and Health in Aging
Type
article
Field-Weighted Citation Impact
2.33

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article

Comparing low volume versus intermediate volume bowel preparation and their impact on work and tolerability: an open-label, noninferiority randomized controlled trial

Adriaan C.I.T.L. Tan, R. M. Schreuder, Milou L. M. van Riswijk, Peter D. Siersema et al.
2 citations
Endoscopy
Nutrition and Health in Aging
2.33
article

Comparing low volume versus intermediate volume bowel preparation and their impact on work and tolerability: an open-label, noninferiority randomized controlled trial

Adriaan C.I.T.L. Tan, R. M. Schreuder, Milou L. M. van Riswijk, Peter D. Siersema, Fleur A. Indemans, Kimberly Hawinkels, Leanne Wildeman
article en
2 citations

Abstract

Bowel preparation is essential for colonoscopy but may deter patients. Although low volume laxatives are better tolerated, their impact on patient-reported outcomes remains unclear. We compared low and intermediate volume bowel preparation and assessed their impact on tolerability, health-related quality of life (HRQoL), and work.We conducted an open-label, noninferiority randomized trial in four Dutch hospitals. Patients were randomized to 2 L polyethylene glycol with ascorbate (2L PEG+Asc) or 1 L with added sodium sulfate (1L PEG+Asc). Before and after preparation, patients completed validated questionnaires on productivity, tolerability, and HRQoL. The primary outcome was the proportion of patients with adequate bowel preparation, aiming to demonstrate noninferiority of 1L PEG+Asc vs. 2L PEG+Asc (5% noninferiority margin). Secondary outcomes included willingness to repeat, with exploratory analysis of associated factors using multivariable logistic regression, change in HRQoL scores, tolerability, and work-related impact.We included 467 patients (2L PEG+Asc, n = 229; 1L PEG+Asc, n = 238). 1L PEG+Asc was noninferior to 2L: adequate cleansing rate, 96.1% (95%CI 92.6% to 98.0%) vs. 96.4% (95%CI 93.0% to 98.3%; <i>P</i> = 0.84; Δ -0.4, 95%CI -4.0 to 3.3). More patients in the 1L PEG+Asc group were willing to repeat the preparation (59.9% vs. 48.3%; <i>P</i> = 0.04), with tolerability the most influential factor (odds ratios 0.05 and 0.22 for difficult or fair vs. good tolerability, adjusted for symptoms, satisfaction, and 1L/2L PEG+Asc). No clinically relevant changes in HRQoL were observed. Absenteeism and impaired work productivity occurred in 7.9% and 12.3%, respectively, with no between-group differences.Bowel preparation with 1L PEG+Asc is noninferior to 2L PEG+Asc and associated with higher willingness to repeat. Tolerability is fundamental for effective cleansing and reducing colonoscopy barriers.

EndoscopyVol. 58(02)
Radboud University Nijmegen (NL), Catharina Ziekenhuis (NL), Erasmus MC (NL), Radboud University Medical Center (NL), Radboud Institute for Molecular Life Sciences (NL), Canisius-Wilhelmina Ziekenhuis (NL), Amalia Kinderziekenhuis (NL), Maaslandziekenhuis (NL)
Norgine
Openalex Percentile: Top 10%
Nutrition and Health in Aging
2.33
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