A Randomized Clinical Trial Evaluating Three Low-volume Preparations for Colonoscopy in Outpatients With Inflammatory Bowel Disease: The Eii-prep Trial.

Abstract

Abstract BACKGROUND: Bowel preparation is crucial for colonoscopies in patients with Inflammatory Bowel Disease (IBD). However, data regarding cleansing solutions in this setting are scarce. AIMS: Our aim was to compare efficacy, safety, and tolerability of three different 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). Primary endpoint was efficacy in terms of percentage of quality cleansing assessed via the Boston Bowel Preparation Scale (BBPS >=6 with segments >=2). Secondary endpoints were efficacy in terms of total high quality cleansing (BBPS 8 or 9), high quality segmental BBPS (>=2) and patients’ tolerability, symptoms, and satisfaction, assessed by questionnaires before and after colonoscopy. Safety was monitored by adverse event reporting, laboratory evaluation at colonoscopy and telephonic follow-up.RESULTS: 92 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). Clinically irrelevant hyponatremia was higher in the SP group (p<0,0001). SP instructions were easier to understand from the 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 between PEG-based bowel preparations and SP regarding efficacy 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.