High-quality cleansing should be a priority for bowel preparations for colonoscopy1
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High-quality cleansing improves adenoma detection, confirmed in a post-hoc combined analysis of three randomised trials (n=1,749)1
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Patients with high-quality cleansing achieve enhanced colorectal cancer prevention1
*Adenoma detection rate vs BBPS scoring by central readers.
ADR, adenoma detection rate; BBPS, Boston Bowel Preparation Scale; n/N, sample size/population size.
Post-hoc analysis from 3 randomised controlled trials in Europe and US; n=1,749.1
Graph adapted from paper.
Reference: 1. Hassan C, et al. Endosc Int Open. 2020;08(7):E928-E937.
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. Esteban JM et al. Endosc Int Open. 2023; 11: 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 Sep;25(5):230-235.
Design Study1
Study design
Post-hoc combined analysis of 3 randomised trials in Europe and the US using patient-level data from all 7 treatment arms of the DAYB, MORA and NOCT trials.
Aim
To assess the adenoma detection rate (ADR) with high-quality (stool-free) cleansing versus adequate-quality cleansing.
Patients
A total of 1,749 patients from DAYB, MORA and NOCT studies with evaluable colonoscopy videos, recorded high quality cleansing (Harefield Cleansing Scale [HCS]) and BBPS scores, and polyp and adenoma counts.
Treatments
PLENVU® versus sodium picosulfate + magnesium citrate; DAYB study with a day before dosing regimen.2
PLENVU® versus MOVIPREP® (2L PEG + ascorbate; MORA study) with an overnight, split-dosing regimen (evening and morning) and a same-day split dosing regimen.3
PLENVU® versus oral trisulfate solution; NOCT study with an overnight, split-dosing regimen (evening and morning).4
Endpoints
To assess the relationship between ADR and colon cleansing quality, particularly stool-free high-quality cleansing:
- HCS: high-quality cleansing (grade A or segmental score 3 or 4) vs adequate-quality cleansing (grade B or segmental score 2)
- BBPS: high-quality cleansing (overall score 9 or segmental score 3) vs adequate-quality cleansing (overall score 6 or segmental score 2).
The original alternative primary endpoints were overall cleansing success and right colon high-quality cleansing success using the HCS by central readers.
The primary endpoint, that ADR increased with high-quality vs adequate quality cleansing scores on both the HCS and BBPS scales, was met. - ADR increased with high-quality vs adequate-quality cleansing:
- HCS grade A = 39% (94/242) vs grade B = 27% (336/1229); number-needed-to-treat (NNT) = 8.7; p<0.001 - ADR increased with high-quality vs uniform adequate segmental cleansing scores:
- HCS grade A = 39% (94/242) versus uniform segmental scores 2 = 26% (97/379); NNT= 7.5; p< 0.001. - ADR increased with excellent-quality vs adequate-quality segmental cleansing scores:
- HCS uniform segmental scores 4 = 54% (21/39) vs 2 = 26% (97/379); NNT = 3.6; p<0.001
- BBPS 9 = 43% (71/166) vs 6 = 26% (247/950); NNT = 6.0; p<0.001 - Right colon ADR increased with excellent quality vs adequate-quality cleansing:
- HCS 4 = 20% (25/122) vs 2 = 11% (121/1117); NNT = 10.4; p<0.001
- BBPS 3 = 15% (42/284) vs 2 = 11% (130/1192); NNT = 25.8; p=0.033.
Statistical analysis
A 1-sided t-test to assess superiority of high-quality versus adequate-quality cleansing on ADR.
Number-needed-to-treat calculated using the reciprocal of the absolute risk reduction and results showing a statistical significance when using the two sided t-test.
Two sided t-test used to derive the 95% confidence interval for the mean adenomas per patient.
Reference: 1. Hassan C, et al. Endosc Int Open. 2020;08(7):E928-E937. 2. Schreiber S, et al. Endoscopy. 2019;51:1-16. 3. Bisschops R, et al. Endoscopy. 2019;51:60-72. 4. deMicco MP, et al. Gastrointest Endoscopy. 2018;87:677-687.
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High-quality cleansing improves sessile serrated polyp (SSP) detection, confirmed in a prospective analysis of male patients undergoing colonoscopy (n=749)2
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For subtle, flat lesions, such as SSPs, the detection rates are negatively impacted by even a small decrease in bowel preparation quality below high-quality3
Aronchick Scale
5-point scale across entire colon from inadequate to excellent:1
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High-quality preparation = excellent (1) or good (2)2
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Intermediate-quality preparation = fair (3)2
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Low-quality preparation = poor (4)2
1 = Excellent
Small volume of clear liquid or >95% of surface seen1
2 = Good
Large volume of clear liquid covering 5% to 25% of the surface but >90% of surface seen1
3 = Fair
Some semi-solid stool that could be suctioned or washed away, but >90% of surface seen1
4 = Poor
Semi-solid stool that could not be suctioned or washed away, and <90% of surface seen1
5 = Inadequate
Repeat preparation required1
References: 1. Sharma P, et al. Endoscopy Int Open. 2020;08(5):E673-E683. 2. Clark BT, Laine L. Clin Gastroenterol Hepatol. 2016;14:1155-1162.
Study Design1
Study design
A prospective, single-centre US study.
Aim
To determine proportions of patients in whom sessile serrated polyps (SSPs) were detected at different levels of bowel preparation quality, using common validated scoring systems.
Patients
A total of 749 male veterans aged 50–75 years, undergoing screening or surveillance colonoscopy.
Treatments
Bowel preparation using validated scoring systems:
- Aronchick scale: high quality preparation defined as either excellent or good, intermediate-quality preparation defined as fair and low-quality preparation defined as poor
- BBPS: high-quality cleansing total BBPS score=7-9; colon segment (right, transverse and left) score=3; adequate-quality cleansing total BBPS score <7; colon segment score=2.
There is no information in the study about the specific bowel preparations.
Endpoints
Primary analysis compared intermediate-quality versus high-quality bowel preparation in the entire colon.
Secondary analyses compared intermediate-quality versus high-quality bowel preparation in the right colon and low-quality versus high-quality preparation in the entire colon and right colon.
Overall and right colon SSP detection rate was defined for each level of bowel preparation quality as the number of those colonoscopies in which at least one SSP was detected divided by the total number of colonoscopies with that level of preparation quality.
Characteristics of all polyps detected were recorded: location, size, morphology and histologic characteristics; only sessile serrated polyps/adenomas and traditional serrated adenomas were included in the SSP definition.
Statistical analysis
Detection rates and 95% confidence intervals (CI) were calculated using the exact method for binomial proportions.
Adjusted odds ratios (ORs) and 95% CIs were calculated using multivariate logistic regression adjusting for subject’s age, indication (screening or surveillance) and endoscopist.
Adjusted OR and 95% CI were used to compare exposure categories.
Reference: 1. Clark BT, Laine L. Clin Gastroenterol Hepatol. 2016;14:1155-1162.
SSP detection rate across the entire colon was significantly higher with high-quality cleansing vs intermediate-quality cleansing using the Aronchick scale2*
*Prospective US study in men; n=749.
CI, confidence interval; OR, odds ratio; n/N, sample size/population size. SSP, sessile serrated polyp.
Detection of SSPs for high-, intermediate- and low-quality bowel preparation (detection rates are per-patient rates).
Graph adapted from paper.
References: 1. Hassan C, et al. Endosc Int Open. 2020;08(7):E928-E937. 2. Clark, BT, Laine L. Clin Gastroenterol Hepatol. 2016;14:1155-1162. 3. Bednarska O, et al. Diagnostics (Basel). 2022;12(5):1155.
