Impact of the Quality of Bowel Cleansing on the Efficacy of Colonic Cancer Screening: A Prospective, Randomized, Blinded Study

Abstract

ObjectivesEfficacy of two low volume bowel cleansing preparations, polyethylene glycol plus ascorbate (PEG+Asc) and sodium picosulfate/magnesium citrate (NaPic/MgCit), were compared for polyp and adenoma detection rate (PDR and ADR) and overall cleansing ability. Primary endpoint was PDR (the number of patients with ≥1 polypoid or flat lesion recorded by the colonoscopist).MethodsDiagnostic, surveillance or screening colonoscopy patients were enrolled into this investigator-blinded, multi-center Phase IV study and randomized 1:1 to receive PEG+Asc (administered the evening before and the morning of colonoscopy, per label) or NaPic/MgCit (administered in the morning and afternoon the day before colonoscopy, per label). The blinded colonoscopist documented any lesion and assessed cleansing quality (Harefield Cleansing Scale).ResultsOf 394 patients who completed the study, 393 (PEG+Asc, N=200; NaPic/MgCit, N=193) had a colonoscopy. Overall PDR for PEG+Asc versus NaPic/MgCit was 51.5% versus 44.0%, p=0.139. PDR and ADR on the right side of the bowel were significantly higher with PEG+Asc versus NaPic/MgCit (PDR: 56[28.0%] versus 32[16.6%], p=0.007; ADR: 42[21.0%] versus 23[11.9%], p=0.015), as was detection of flat lesions (43[21.5%] versus 25[13.0%], p=0.025). Cleansing quality was better with PEG+Asc than NaPic/MgCit (98.5% versus 57.5% considered successful cleansing). Overall, there were 132 treatment-emergent adverse events (93 versus 39 for PEG+Asc and NaPic/MgCit, respectively). These were mainly mild abdominal symptoms, all of which were reported for higher proportions of patients in the PEG+Asc than NaPic/MgCit group. Twice as many patients in the NaPic/MgCit versus the PEG+Asc group reported tolerance of cleansing solution as ‘very good’.ConclusionsCompared with NaPic/MgCit, PEG+Asc may be more efficacious for overall cleansing ability, and subsequent detection of right-sided and flat lesions. This is likely attributable to the different administration schedules of the two bowel cleansing preparations, which may positively impact the detection and prevention of colorectal cancer, thereby improving mortality rates.Trial RegistrationClinicalTrials.gov NCT01689792.

Improved high-quality colon cleansing with 1L NER1006 versus 2L polyethylene glycol + ascorbate or oral sulfate solution

“…This analysis better reflects the real-world cleansing performance of NER1006 versus current alternatives such as 2LPEG (MOVIPREP ® , Norgine Ltd, Harefield, UK; assessed in the MORA trial) and oral sulfate solution (OSS; SUPREP ® , Braintree Laboratories, Braintree, MA, USA; assessed in the NOCT trial). These two comparators are both widely used and known for their high cleansing efficacy [23][24][25][26][27]. For a robust assessment of comparative cleansing efficacy, three complementary efficacy measures were analyzed: first, the patient-level rates of standard HCS overall colon cleansing success; then, the patient-level rate of overall high-quality cleansing; finally, the rate of segments cleansed at high-quality across the patient population ('population-level').…”

Increased Risk of Synchronous Colorectal Lesions in Patients Referred for Endoscopic Mucosal Resection of Lateral Spreading Tumors

“…Colonoscopy as a screening method is not flawless: its diagnostic efficacy depends on bowel cleansing quality, operator accuracy in detecting mucosal lesions and endoscope withdrawal time to mention a few (10,11) . As a matter of fact, mucosal lesions -even polypoid adenomas -can be missed, which constitute a significant risk factor for interval CRC.…”

Lifestyle Factors and Bowel Preparation for Screening Colonoscopy

“…The presence of adenomatous polyps affects the risk of CRC after screening colonoscopy [ 3 ]. Detection of adenomas, however, depends on the ability to visualize the colonic mucosa, emphasizing the importance of bowel preparation [ 4 - 6 ]. However, bowel preparation at the time of colonoscopy is found to be suboptimal in about 20% of subjects [ 5 ].…”