Abstract
BackgroundThe right colon is difficult to cleanse compared with other colon segments. This post hoc analysis of two randomised clinical trials (MORA and NOCT) examined whether 1L polyethylene glycol (PEG) NER1006 and two mid-volume alternatives could improve adequate and high-quality cleansing in the right colon among patients with complete cleansing assessments.MethodsPatients received NER1006 (N2D), 2L PEG plus ascorbate (2LPEG) or oral sulphate solution (OSS) as a 2-day evening/morning split-dosing regimen or NER1006 as a same-day morning-only dosing regimen (N1D). Patients had full segmental scoring assigned by treatment-blinded central readers using the Harefield Cleansing Scale. The right colon adequate (score ≥ 2) and high-quality (score ≥ 3) cleansing success of NER1006 (N2D and N1D) versus 2LPEG and OSS was analysed individually and as pooled groups (N2D vs. 2LPEG/OSS). We assessed the comparative right colon cleansing rates of the N2D versus 2LPEG/OSS in overweight males. We also performed a multivariable regression analysis to examine factors affecting cleansing in the right colon.ResultsA total of 1307 patients were included. Pooled N2D showed significantly improved rates of adequate-level cleansing in the right colon compared with 2LPEG (97.5% [504/517] vs. 94.6% [246/260]; p = 0.020) and OSS (97.5% [504/517] vs. 93.8% [244/260]; p = 0.006). In MORA, the rate of adequate right colon cleansing did not significantly differ between N1D and 2LPEG (95.2% [257/270] vs. 94.6% [246/260]; p = 0.383). The rate of right colon high-quality cleansing was significantly improved with N2D or N1D vs. 2LPEG (p < 0.001 for both), and was numerically higher with N2D versus OSS (p = 0.11). In overweight males, NER1006 delivered numerically higher adequate (p = 0.398) and superior high-quality (p = 0.024) cleansing rates versus 2LPEG/OSS. Multivariable regression analysis showed NER1006 was associated with adequate and high-quality cleansing (p = 0.031 and p < 0.001), while time between preparation and colonoscopy was negatively associated (p = 0.034 and p = 0.006).ConclusionsNER1006 delivered improved rates of adequate and high-quality right colon cleansing compared with 2LPEG and OSS. The increased rate of high-quality cleansing with NER1006 versus its comparators was also seen in overweight males.
Highlights
The right colon is difficult to cleanse compared with other colon segments
Patients The MORA and NOCT trials included both male and female patients aged 18–85 years with varied demographic and clinical characteristics who required a screening, surveillance or diagnostic colonoscopy. This post hoc analysis mainly used data from the modified full analysis set 2 of the two trials, which included all patients with full segmental Harefield Cleansing Scale (HCS) scorings by treatment-blinded central readers
We studied the cleansing efficacy of NER1006 2-day evening/morning split-dosing regimen (N2D) versus 2L polyethylene glycol (PEG) plus ascorbate (2LPEG)/oral sulphate solution (OSS) in the right colon of males with body mass index (BMI) ≥ 25 kg/m2, as these patients are commonly known to be at increased risk for both inadequate cleansing and colorectal cancer (CRC) [17]
Summary
The right colon is difficult to cleanse compared with other colon segments. This post hoc analysis of two randomised clinical trials (MORA and NOCT) examined whether 1L polyethylene glycol (PEG) NER1006 and two mid-volume alternatives could improve adequate and high-quality cleansing in the right colon among patients with complete cleansing assessments. Adequate bowel preparation is an essential pre-procedural clinical requirement that determines the diagnostic yield and therapeutic benefits of colonoscopy [2]. Adequate cleansing is more difficult to attain in the right colon compared with other colon segments [5]. Ensuring successful cleansing in the right colon is fundamental to maximising the protection against right-sided CRCs
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