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DOI: 10.1055/s-0039-1681330
MORE LESIONS PER PATIENT DETECTED WITH HIGH-QUALITY VERSUS ADEQUATE COLON CLEANSING: A POST HOC ANALYSIS OF UNIFORM SEGMENTAL CLEANSING SCORES USING THE HAREFIELD CLEANSING SCALE
Publication History
Publication Date:
18 March 2019 (online)
Aims:
Effective colonoscopy requires colon cleansing success which is usually based on the least clean colon segment; one poorly cleansed segment triggers an overall failure. This complicates the analysis of cleansing quality versus lesion detection. We therefore analysed the relative lesion detection in patients who had the same cleansing score in all colon segments.
Methods:
Three similar phase 3 clinical trials assessed the colon cleansing efficacy of 1L NER1006 (PLENVU) versus standard bowel preparations. Cleansing quality assessment was standardised with treatment-blinded central readers using the validated Harefield Cleansing Scale (HCS). Lesions were detected by site endoscopists as per usual clinical practice. Trial results were pooled for this post hoc analysis. The mean number of polyps (MPP) and adenomas (MAP) per patient were calculated in patients with uniform segmental scores ranging from zero (failure) to four (high-quality). One-sided t-tests assuming equal variance assessed MPP and MAP of HCS 4+4+4+4+4 versus lower score groups.
Results:
Among 1749 patients included in this analysis, 469 had uniform segmental scores (Table). HCS 4+4+4+4+4 demonstrated a higher MAP vs. HCS 2+2+2+2+2 (1.18 vs. 0.51; P = 0.001) or HCS 1+1+1+1+1 (1.18 vs. 0.10; P = 0.034). MPP was improved with HCS 4+4+4+4+4 vs. HCS 1+1+1+1+1 (1.92 vs. 0.60; P = 0.048). Four patients had HCS uniform scores of zero; no lesions were detected in these patients.
Uniform segmental HCS scores 1 – 4 |
High-quality 4+4+4+4+4 |
High-quality 3+3+3+3+3 |
Adequate 2+2+2+2+2 |
Failure 1+1+1+1+1 |
Sample size, N |
39 |
37 |
379 |
10 |
Polyps per patient, Mean (SD); P-value vs. 4+4+4+4+4 |
1.92 (2.39) |
1.27 (2.05); P = 0.103 |
1.21 (2.59) P = 0.050 |
0.60 (1.07) P = 0.048 |
Adenomas per patient, Mean (SD); P-value vs. 4+4+4+4+4 |
1.18 (1.80) |
0.70 (1.24); P = 0.093 |
0.51 (1.18) P = 0.001 |
0.10 (0.32) P = 0.034 |
Conclusions:
Despite variable sample sizes, this analysis demonstrated a higher MAP for high-quality versus adequate cleansing success and a consistent trend towards improved lesion detection with higher cleansing quality.