Randomized clinical trial evaluating three low-volume preparations for colonoscopy in outpatients with Inflammatory Bowel Disease: the EII-PREP trial

• Published in: Scandinavian journal of gastroenterology Vol. 58; no. 6; pp. 656 - 663
• Main Authors: Rueda García, Jose Luis, Suárez Ferrer, Cristina, Martín-Arranz, Eduardo, García-Ramírez, Laura, Sánchez-Azofra, María, Poza Cordón, Joaquín, Noci, Jesús, Vergés, Tamara, Blanco San Miguel, Paula, Martín-Arranz, María Dolores
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 03-06-2023
• Subjects: bowel preparation; Cathartics - adverse effects; Colonoscopy; Crohn's disease; Humans; Inflammatory bowel disease; Inflammatory Bowel Diseases - chemically induced; Outpatients; polyethylene glycol; Polyethylene Glycols - adverse effects; sodium picosulfate; split-dose regimen; ulcerative colitis; Inflammatory bowel disease; bowel preparation; polyethylene glycol; split-dose regimen; ulcerative colitis; sodium picosulfate; colonoscopy; Crohn’s disease
• ISSN: 0036-5521; 1502-7708
• DOI: 10.1080/00365521.2022.2153618

Data regarding bowel preparation in patients with Inflammatory Bowel Disease (IBD) are scarce.
To compare efficacy, safety, and tolerability of low-volume preparations in patients with IBD.
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.
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.
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.
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.