Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study

Abstract

Background Standard high-volume polyethylene glycol [PEG] bowel preparations [PEG-4L] are recommended for patients with inflammatory bowel disease [IBD] undergoing colonoscopy. However, low-volume preparations [≤2 L of active volume] are often used in clinical practice. The aim of this study was to evaluate the efficacy, tolerability, and safety of the various bowel preparations for patients with IBD, including low-volume preparations. Methods We conducted a French prospective multicentre observational study over a period of 1 month. Patients aged 18–75 years with IBD with an indication of colonoscopy independent of the study were enrolled. The choice of the preparation was left to the investigators, as per their usual protocol. The patients’ characteristics, disease, and colonoscopy characteristics were recorded, and they were given self-reported questionnaires. Results Twenty-five public and private hospitals enrolled 278 patients. Among them, 46 had a disease flare and 41 had bowel stenoses. Bowel preparations for colonoscopy were as follows: 42% received PEG-2L, 29% received sodium picosulfate [Pico], 15% received PEG-4L, and 14% had other preparations. The preparation did not reach the Boston’s score efficacy outcome in the PEG-4L group in 51.2% of the patients [p = 0.0011]. The preparation intake was complete for 59.5% in the PEG-4L group, compared with 82.9% in the PEG-2L group and 93.8% in the Pico group [p < 0.0001]. Tolerability, as assessed by the patients’ VAS, was significantly better for both Pico and PEG-2L compared with PEG-4L, and better for Pico compared with PEG-2L [p = 0.008; p = 0.0003]. In multivariate analyses, low-volume preparations were independent factors of efficacy and tolerability. Adverse events occurred in 4.3% of the patients. Conclusions Preparations with PEG-2L and Pico were equally safe, with better efficacy and tolerability outcomes compared with PEG-4L preparations. The best efficacy/tolerance/safety profile was achieved with the Pico preparation.

Evaluating patient acceptability and bowel preparation efficacy of sodium picosulfate‐magnesium citrate for colonoscopy

“… 18 , 19 Moreover, in a multicenter observational study conducted in France on the best colonoscopy preparation agent for inflammatory bowel disease, both agents PICOPREP and PEG‐2L were equally safe and were reported to have significantly better efficacy and patient acceptability than PEG‐4L. 20 In this study, UC was observed in 33 patients (61.1%), a well‐known cause of unknown chronic diseases. Therefore, a stable remission period should be considered for long‐term treatment.…”

“…According to the consensus statement and guidelines compiled by the American and European academic societies, the effectiveness of PICOPREP is evaluated to be almost the same as that of conventional PEG 18,19 . Moreover, in a multicenter observational study conducted in France on the best colonoscopy preparation agent for inflammatory bowel disease, both agents PICOPREP and PEG‐2L were equally safe and were reported to have significantly better efficacy and patient acceptability than PEG‐4L 20 . In this study, UC was observed in 33 patients (61.1%), a well‐known cause of unknown chronic diseases.…”

Efficacy and Tolerability of Two Different Low-Volume Split-Dose Polyethylene Glycol Electrolytes Solution Bowel Preparation for Morning Colonoscopy

“…Therefore, the quality of bowel preparation requirements will be higher. More recently, consistent literature data confirmed that high-quality bowel preparation is a key factor in endoscopy [ 29 , 30 ]. In this study, the satisfaction rate of adequate bowel preparation in the 1.5 L + 0.75 L group was higher than in the 0.75 L + 1.5 L group, and we analyzed the reasons and found in clinical practice, although the patients in both groups completed bowel cleansing according to the corresponding bowel preparation regimen, and determined that their last stool was clear water, the patients in the 1.5 L + 0.75 L group tolerated higher, and the proportion of vomiting was less than that of the 0.75 L + 1.5 L group, so the bowel cleansing of the patients in the 1.5 L + 0.75 L group was better than that of the 0.75 L + 1.5 L group.…”

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

“…Only 2 of those studies have been performed in recent years (2015 and 2017) (15) (16): they were both randomized trials and compared large-volume PEG (4L-PEG) with 2L-PEG plus ascorbic acid/bisacodyl; however, they only admitted patients with inactive UC. The 2019 French Multicenter CLEAN study (17) is the largest and most recent study regarding this matter. It found no differences between 4L-PEG vs 2L-PEG and SP regarding colon cleansing, in both CD and UC; and though prospective, its design was observational.…”

“…Trials by Manes et al (15) and Kim et al (16) found no differences regarding colon cleansing between 4L-PEG and 2L-PEG; however, differences in design (i.e., use of high-volume preparations and excluding patients with CD) hindered us from comparing our data. The CLEAN trial (17) found that 2L-PEG and SP were signi cantly superior (p = 0.0021 and 0.0020, respectively) to 4L-PEG for colon cleansing in all subtypes of IBD. The mean BBPS in the CLEAN study was 7.6 for 2L-PEG and 7.7 for SP; our results numerically favored SP (7.35 for 2L-PEG and 8.09 for SP) but did not reach statistical signi cance.…”