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.