https://orcid.org/0000-0003-4487-452X
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Abstract
Background
Data regarding bowel preparation in patients with Inflammatory Bowel Disease (IBD) are scarce.
Aim
To compare efficacy, safety, and tolerability of low-volume preparations in patients with IBD.
Methods
Single-center, randomized, prescriber, and colonoscopist-blinded clinical trial. IBD outpatients undergoing colonoscopy were randomized 1:1:1 to receive 1 Liter-polyethylene glycol-ascorbate (1L-PEG), 2 Liters-PEG, or sodium picosulfate (SP). The primary endpoint was percentage of quality cleansing assessed via the Boston Bowel Preparation Scale (BBPS ≥6, segments ≥2). Secondary endpoints were total high quality cleansing (BBPS 8 or 9), high-quality segmental BBPS (≥2), and patients’ tolerability, symptoms, and satisfaction, assessed by questionnaires. Safety was monitored by adverse event reporting, laboratory evaluation at colonoscopy, and telephonic follow-up.
Results
Ninety-two patients were included (33 1L-PEG, 28 2L-PEG, and 31 SP). No significant differences between preparations were observed in quality or high-quality total BBPS or high-quality segmental BBPS. Complete intake of the solution was higher for SP (p = 0.006) and lower for 1L-PEG (p = 0.02) compared to 2L-PEG intake (p = 0.55). Clinically irrelevant hyponatremia was higher in the SP group (p < 0.0001). SP instructions were easier to understand from patient’s point of view (p = 0.01). Willingness to retake was higher with SP (p < 0.0001) and less for 1L-PEG (p < 0.0001). No serious adverse events were reported.
Conclusions
We observed no differences in efficacy between low-volume preparations in patients with IBD. Complete intake was higher for SP and lower for 1L-PEG. SP and 2L-PEG instructions were better understood and graded, and SP was more likely to be retaken. Willingness to retake was lower for 1L-PEG. No serious adverse events were reported.
Summary
No differences in terms of efficacy were regarded in this clinical trial comparing low-volume preparations for colonoscopy in patients with IBD: however, Sodium Pisoculfate is better tolerated and accepted from patient’s point of view. No serious adverse events were reported.
Acknowledgements
We thank nurses from the endoscopy unit as well as all training residents for their assistance in the development of the trial.
Ethical approval
Ethics approval was sought and obtained before the initiation of the study from the Local Ethics Committee of University Hospital La Paz (Local code 5224). All participants provided written informed consent before their inclusion in the trial.
Author contributions
C.S.F.: study design. J.L.R. and C.S.F: acquired, analyzed, and interpreted the data. C.S.F.: performed the statistical analysis. J.L.R.: drafted the manuscript. C.S.F., J.P.C., E.M.A., M.S.A., L.G.R., J.N., T.V., P.B.S.M., and M.D.M.A.: revised the manuscript critically and contributed important intellectual content.
Disclosure statement
J.L.R.G. has served as a speaker for Janssen and has received financial support for traveling and educational activities from Janssen, Takeda, Pfizer, Ferring, Tillotts Pharma, Faes Farma, Norgine, and Casen. C.S.F. has received financial support for traveling and educational activities or has received fees as a speaker or consultant from Ferring, MSD, Janssen, Takeda, and Tillotts Pharma. E.M.A. has received financial support for traveling and educational activities or has received fees as a speaker or consultant from Ferring, MSD, AbbVie, and Takeda. M.S.A. has served as a speaker for Janssen and has received financial support for traveling and educational activities from Takeda, Janssen, Tillotts Pharma, and Ferring. J.P.C. has received financial support for traveling and educational activities from AbbVie, Janssen, Kern Pharma, Pfizer, MSD, Amgen, Takeda, Ferring, Shire, and Tillotts Pharma. M.D.M.A. has received fees as a speaker, consultant, and advisory member or has received research funding from MSD, AbbVie, Hospira, Pfizer, Takeda, Janssen, Shire Pharmaceuticals, Tillotts Pharma, and Faes Pharma. The remaining authors do not disclose conflicts of interest.
Data availability statement
Raw data were generated at University Hospital La Paz. Derived data supporting the findings of this study are available from the corresponding author (J.L.R.G.) on request.