Study design
Qualitative, prospective, multicentre, comparative, single-blind, observational real-world setting study in 6 Swedish outpatient centres.
Aim
To assess the effectiveness and tolerability of 1L PEG-ASC (PLENVU®) compared to low-volume 2L PEG-ASC and high volume 4L PEG solutions in a real-world setting.
Patients
A total of 1,098 outpatients aged ≥18 years requiring bowel preparation for screening, surveillance or diagnostic colonoscopy.
Patients were consecutively enrolled from both the external and internal study centre referral lists.
Treatments
Patients were consecutively assigned to one of the two study groups with an overnight split-dose regimen applied throughout:
- 1L PEG-ASC (PLENVU®)
- 2L PEG-ASC (MOVIPREP®) or 4L PEG according to local routines.
Endpoints
Bowel cleansing effectiveness using the BBPS:
- Adequate-quality cleansing defined as a total BBPS≥6 with a partial BBPS≥2 in each colon segment
- High-quality cleansing defined as total BBPS=9 with right colon BBPS=3.
Caecal intubation rate and, need and reason for colonoscopy rescheduling were documented in a patient questionnaire.
Patient experience with the study preparation recorded using a 5-point Likert scale (smell, taste, total volume of laxative ingested, total fluid ingested and total experience).
Tolerability was recorded with respect to nausea (PLENVU® = 43%, MOVIPREP® = 22%, p<0.001; 4L PEG = 37%, p=0.059 vs PLENVU®) and vomiting (PLENVU® = 12%, MOVIPREP® = 4%, p=0.002; 4L PEG = 5%, p=0.011 vs PLENVU®).
Statistical analysis
One-way analysis of variance (ANOVA) and Tukey post-hoc analyses were used for comparisons with continuous variables.
Kruskal–Wallis one-way ANOVA with Bonferroni corrections were used for ordinal variables.
Pearson Chi-Square test was used for categorical variables.
All tests were 2-tailed.
Likert scale results utilised medians and percentiles