PLENVU® provides higher overall cleansing and high-quality right colon cleansing vs 4L PEG1
Boston Bowel Preparation Scale
Ratings for 3 colon segments (right, left and transverse) on a 4-point scale:1
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High-quality cleansing = overall score of ≥82 (or 9 depending on study3) for whole colon or score 3 at segmental level.3
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Adequate-quality cleansing = overall score of ≥6 for whole colon or score ≥2 at segmental level.3
BBPS Score3,4
3 = Excellent
Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid3
2 = Good
Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well3
1 = Poor
Portion of mucosa of colon segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid3
0 = Inadequate
Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared3
The final, published version of this article is available at https://karger.com/pjg/article-pdf/25/5/230/3438373/000485567.pdf
References: 1. Sharma P, et al. Endoscopy Int Open. 2020;08(5):E673-E683. 2. López-Jamar JME, et al. Endosc Int Open. 2023;11(8);E785-E793. 3. Hassan C, et al. Endosc Int Open. 2020;08(7):E928-E937. 4. Massinha P, et al GE Port J Gastroenterol. 2018;25(5):230-235.
Study Design1
Study design
A prospective, multicentre, randomised, single-blinded non-inferiority study in 10 Italian centres.
Aim
To compare the efficacy, safety and tolerability of 1L PEG-ASC (PLENVU®) versus a 4L PEG preparation in both inpatients and outpatients.
Patients
A total of 478 patients aged ≥18 years and ≤85 years undergoing a screening, surveillance or diagnostic colonoscopy consecutively enrolled in 10 Italian centres from March to September 2022.
A total of 433 patients met the inclusion criteria for the efficacy arm and 446 for the tolerability arm.
Treatments
Patients were randomly assigned to one of the following treatments taken as either a split dose (afternoon-morning regimen) or same-day treatment regimen:
- 1L PEG-ASC (PLENVU®) • 4L PEG.
Endpoints
Assessment of bowel cleansing success:
- Adequate bowel cleansing: total BBPS ≥6 with a segmental BBPS ≥2
- Excellent bowel cleansing: total BBPS=9
- High-quality cleansing of the right colon as a partial BBPS=3.
- Tolerability was assessed based on the occurrence and grading (mild, moderate or severe) of the adverse events during or after the bowel preparation.
Safety was monitored through adverse event reporting.
Adverse events included:
Nausea (PLENVU® = 67.6%, 4L PEG = 58.4%, p=0.045) and thirst (PLENVU® = 2.7%, 4L PEG = 0%, p=0.03) were more frequent with PLENVU®. Bowel distension (PLENVU® = 50.2%, 4L PEG = 59.7%, p=0.044) and abdominal pain/cramps (PLENVU® = 36.4%, 4L PEG = 49.3%, p=0.006) were more common with 4L PEG. There was no significant difference in the incidence of vomiting (PLENVU® = 8.9%, 4L PEG = 5%, p=0.104).
Treatment compliance was scored using a 3-grade scale and recording the amount of fluid/food consumption.
Adherence was defined as the consumption of at least 75% preparation dose.
All detected lesions were measured and classified according to size, morphology and location.
Statistical analysis
Non-inferiority of the primary endpoint (overall cleansing success) was proven if the lower 2-sided 95% confidence interval (CI) for the difference between treatments was ≥–10 %. If non-inferiority was met for the primary endpoint, the same was subsequently assessed for superiority using Fisher exact test.
Reference: 1. Vassallo R, et al. Dig Liver Dis. 2024;256(3):495-501.
BBPS, Boston Bowel Preparation Scale.1
Prospective, single-blinded, noninferiority, multicentre, randomised study; n=433 for efficacy analysis, n=446 for tolerability arm.1
Graph adapted from paper.
Reference: 1. Vassallo R, et al. Dig Liver Dis. 2024;256(3):495-501.
