scholarly journals Bowel preparation with 1L polyethylene glycol and ascorbate NER1006 doubles the chance to detect three or more adenomas in overweight or obese males

2021 ◽  
Vol 09 (09) ◽  
pp. E1324-E1334
Author(s):  
Michael Epstein ◽  
Juha Halonen ◽  
Prateek Sharma

Abstract Background and study aims Men have more colon cleansing failures, colorectal adenomas, and colorectal cancers than women. We analyzed whether 1-liter (1 L) polyethylene glycol (PEG) NER1006 improves high-quality (HQ) colon cleansing and adenoma detection in males versus two mid-volume alternatives. Patients and methods The analysis of 1028 adult patients in two randomized clinical trials was performed. Adenoma detection and HQ cleansing were compared for overnight split dosing regimens with NER1006 (n = 513) versus combined oral sulfate solution or 2 L PEG + ascorbate (OSS/2 L PEG) (n = 515). Analyses included males versus females, overweight or obese (OO) males versus lean males, and NER1006 versus OSS/2 L PEG. In male patients, the adenoma detection rate of at least 3 (ADR3 +) was predicted with multiple logistic regression and statistical comparisons used the two-sided t-test. Results ADR3 + was greater in males versus females (10.7 % [56/524] versus 5.8 % [29/504]; P = 0.004) despite comparable adequate cleansing success rates (93.2 % [479/514] versus 93.0 % [466/501]; P = 0.912) and more HQ-scores in females (41.6 % [1069/2570] versus 45.3 % [1134/2505]; P = 0.008). ADR was almost twice as high in OO versus lean males (43.4 % [184/424] versus 23.1 % [21/91]; P < 0.001). Multivariate logistic regression predicted ADR3 + detection to be twice as likely in OO males using NER1006 versus OSS/2 L PEG (odds ratio (95 % confidence interval [CI]) = 2.049 (1.082–3.973); P = 0.030) and 90 % more likely in all males (1.902 (1.045–3.526); P = 0.037). In males, including OO males, NER1006 attained more HQ-scores per trial than OSS or 2 L PEG (P ≤ 0.017 for all comparisons). Conclusions NER1006 predicted the detection of more males for frequent surveillance than OSS/2 L PEG.

2020 ◽  
Vol 08 (05) ◽  
pp. E628-E635
Author(s):  
Michael S. Epstein ◽  
Robert Benamouzig ◽  
Juha Halonen ◽  
Raf Bisschops

Abstract Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.


2020 ◽  
Vol 08 (07) ◽  
pp. E928-E937
Author(s):  
Cesare Hassan ◽  
Jonathan Manning ◽  
Marco Antonio Álvarez González ◽  
Prateek Sharma ◽  
Michael Epstein ◽  
...  

Abstract Background and study aims Reliable adenoma detection requires “adequate” bowel preparation. The adenoma detection rate (ADR) was assessed in patients with high-quality (stool-free) cleansing versus adequate cleansing. Patients and methods This study was a post-hoc combined analysis of three randomized trials individually powered for cleansing quality assessment. Treatment-independent ADR was assessed versus colon cleansing quality by central readers using the Harefield Cleansing Scale (HCS) and the Boston Bowel Preparation Scale (BBPS). The number needed to treat (NNT) to find an additional patient with at least one adenoma was calculated for high-quality versus adequate-quality cleansing. Results A total of 1749 patients were included. ADR increased with high-quality versus adequate-quality cleansing: HCS grade A versus B, 39 % (94/242) versus 27 % (336/1229); NNT = 8.7; P < 0.001. ADR also increased with high-quality versus uniform adequate segmental cleansing scores: HCS grade A versus uniform segmental scores 2, 39 % (94/242) versus 26 % (97/379); NNT = 7.5; P < 0.001. ADR increased with top-quality versus adequate segmental cleansing scores: HCS uniform segmental scores 4 versus 2, 54 % (21/39) versus 26 % (97/379); NNT = 3.6; P < 0.001. ADR increased with BBPS 9 versus 6, 43 % (71/166) versus 26 % (247/950); NNT = 6.0; P < 0.001. Right colon ADR increased with top-quality versus adequate cleansing: HCS 4 versus 2, 20 % (25/122) versus 11 % (121/1117); NNT = 10.4; P < 0.001 and BBPS 3 versus 2, 15 % (42/284) versus 11 % (130/1192); NNT = 25.8; P = 0.033. Conclusions High-quality colon cleansing improves adenoma detection, and it should be a priority for bowel preparations for colonoscopy.


2019 ◽  
Vol 89 (6) ◽  
pp. AB415
Author(s):  
Daniel C. Baumgart ◽  
Jürgen Gschossmann ◽  
Bharat Amlani ◽  
Alessandro Repici

2021 ◽  
Vol 58 (12) ◽  
pp. 1119-1123
Author(s):  
Phan Thi Hien ◽  
Vu Huu Thoi ◽  
Nguyen Thu Ha ◽  
Nicolas Kalach

Sign in / Sign up

Export Citation Format

Share Document