- Fecal Incontinence
|Randomized clinical trial evaluating three low-volume preparations for colonoscopy in outpatients with Inflammatory Bowel Disease: the EII-PREP trial
Scand J Gastroenterol. 2023 Jun;58(6):656-663.doi: 10.1080/00365521.2022.2153618. Epub 2022 Dec 15.
Jose Luis Rueda García 1 2, Cristina Suárez Ferrer 1 2, Eduardo Martín-Arranz 1 2, Laura García-Ramírez 1 2, María Sánchez-Azofra 1 2, Joaquín Poza Cordón 1 2, Jesús Noci 1 2, Tamara Vergés 1 2, Paula Blanco San Miguel 1 2, María Dolores Martín-Arranz 1 2 3; IdiPAZ Study Group for Immune-Mediated Gastrointestinal Diseases
1Inflammatory Bowel Disease Unit, Gastroenterology Department, La Paz University Hospital, Madrid, Spain.
2La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.
3School of Medicine, Autonomous University of Madrid, Madrid, Spain.
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.