Dataset Information

Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study.

ABSTRACT:

Objectives

Efficacy 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).

Methods

Diagnostic, 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).

Results

Of 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'.

Conclusions

Compared 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 registration

ClinicalTrials.gov NCT01689792.

SUBMITTER: Pohl J

PROVIDER: S-EPMC4423835 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study.

Pohl Jürgen J Halphen Marc M Kloess Hans Rudolf HR Fischbach Wolfgang W

PloS one 20150507 5

<h4>Objectives</h4>Efficacy 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).<h4>Methods</h4>Diagnostic, surveillance or screening colonoscopy patients were enrolled into this investigator- ...[more]

PMID: 25950434

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Project description:AimTo evaluate the sensory characteristics of commercial bowel cleansing preparations.MethodsSamples of 4 commercially available bowel cleansing preparations, namely polyethylene glycol electrolyte solution (PEG), PEG + ascorbic acid (PEG-Asc), sodium picosulfate (SPS), and oral sodium sulfate (OSS) were prepared according to the manufacturer's instructions. Descriptive analysis was conducted (n = 14) using a 15-cm line scale with the Compusense at-hand(®) sensory evaluation software. Acceptability testing (n = 80) was conducted using the 9-point hedonic scale. In addition, a Just-About-Right (JAR) scale was included for the four basic tastes to determine their intensity compatibility with acceptability levels in the products.ResultsSamples were significantly different, in descriptive analysis, for all attributes (P < 0.05) except for sweetness. SPS received the highest ratings for turbidity, viscosity appearance, orange odor and orange flavor; PEG-Asc for citrus odor and citrus flavor; OSS for sweetener taste, sweet aftertaste, bitterness, astringency, mouthcoating, bitter aftertaste and throatburn, and along with PEG-Asc, the highest ratings for saltiness, sourness and adhesiveness. Acceptability results showed significant differences between the various samples (P < 0.05). SPS received significantly higher ratings for overall acceptability, acceptability of taste, odor and mouthfeel (P < 0.05). JAR ratings showed that PEG and PEG-Asc were perceived as slightly too salty; SPS and OSS were slightly too sweet, while SPS, PEG-Asc and OSS were slightly too sour and OSS slightly too bitter. While using small sample volumes was necessary to avoid unwanted purgative effects, acceptability ratings do not reflect the true effect of large volumes intake thus limiting the generalization of the results.ConclusionFurther improvements are needed to enhance the sensory profile and to optimize the acceptability for better compliance with these bowel cleansing solutions.

Project description:Background and aimswater is an imperfect agent for lens cleansing during endoscopy due to its incompetence to clean hydrophobic dirt, whereas amphiphilic surfactants have the potential to overcome the limitation of water. The trial was aimed to evaluate the cleansing effectiveness of 2 typical surfactants (simethicone solution and oolong tea) for colonoscopic lens.MethodsOolong tea (O-), low concentration simethicone solution (S1-), high concentration simethicone solution (S2-) and distilled water (D-) were used as washing solutions for colonoscopic lens. Study I: The tip of the colonoscope was immersed in lard oil in order to simulate the blur, and photographs were taken toward a standard colonoscopy image in-vitro pre- and post- each cleansing procedure. The blurred areas of each image were quantified and compared. Study II: 395 consecutive patients who were due to colonoscopy examination were enrolled and randomized into O-, S2-, D-group. The volume of washing solution used and cleansing level during the examination procedure, adenoma and polyp detected per colonoscopy, insertion time and withdraw time were analyzed.ResultsStudy I: There were no differences in 4 groups for the blurred areas on images before lens cleansing. The blurred areas after lens cleansing were significantly smaller in 3 groups (O- 8.47 ± 20.91 vs S1- 13.06 ± 10.71 vs S2- 6.76 ± 8.49 vs D- 38.24 ± 29.69, P < .05) than water. The decline range of blurred areas after lens cleansing in oolong tea, low concentration simethicone solution, high concentration simethicone solution groups were significantly higher than that in distilled water group (O- 87.35 ± 20.81 vs S1- 78.12 ± 19.24 vs S2- 89.57 ± 8.50 vs D- 53.39 ± 28.45, P < .05). Study II: The volume of washing solution used in S2-group was significantly smaller than that in O-group and D-group. The cleansing level of the colonoscopic lens of O-group was significantly superior than that of S2-group and D-group.ConclusionsThe in-vitro test showed oolong tea and simethicone solution can effectively cleans the colonoscopic lens. The clinical trial demonstrated that oolong tea instead of water is effective to provide better visualization during colonoscopy.Registration: Chictr.org.cn No: ChiCTR1900025606.

Project description:Abstract Aims Failed bowel preparation is common during colonoscopy, yet the optimal purgative regimen to use for the next attempt is unknown. The objective of this study was to compare the efficacy, tolerability, and safety of two regimens at supratherapeutic doses for use after failed bowel preparation. Methods A multi-centre phase III endoscopist blinded randomized controlled trial (NCT02976805) was conducted in patients who failed bowel preparation, using the US Multi-Society Task Force (USMSTF) definition of inability to exclude polyps >5 mm in size and requiring a shortened interval to next colonoscopy. Regimen A consisted of 15 mg of bisacodyl and 2 + 2 L of split dose polyethylene glycol electrolyte solution (PEG) and Regimen B consisted of 15 mg of bisacodyl and 4 + 2 L of split dose PEG. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥ 6 with all segment scores ≥ 2. Secondary outcomes were adequate bowel preparation using the USMSTF definition, median BBPS, adenoma detection (ADR), advanced adenoma detection (aADR), sessile serrated polyp detection (SSPDR), and cecal intubation (CIR). Adverse events were assessed at the time of the colonoscopy and 14 days later. Results Between February 2017 and December 2019, 250 subjects were screened at four academic centres in Canada, of which 195 were randomized: 96 to Regimen A and 99 to Regimen B. The mean (SD) age was 60.6 (11.4) years, 87 (45.1%) were female, and the median (IQR) total BBPS score at previous failed colonoscopy was 3 (1,4). Regimen B was not superior to Regimen A in achieving adequate bowel preparation using the BBPS definition (87.6% vs. 91.1%, p=0.45) or the USMSTF definition (85.4% vs 91.1%, p=0.24), nor was it superior with respect to the median BBPS score (7 vs 7, p=0.50), mean ADR (31.5% vs 37.8%, p=0.37), aADR (11.2% vs 18.9%, p=0.15), SSPDR (5.6% vs 8.9%, p=0.40) or CIR (92.1% vs 96.7%, p=0.19). Regimen A had a higher adherence rate (88.2% vs. 74.7%, p=0.02) and greater willingness to undergo the bowel preparation again (91.2% vs. 66.2%, p<0.001). The only serious adverse event occurred in a patient randomized to Regimen B who was admitted to hospital for vomiting after colonoscopy. Conclusions Split dose 4L PEG with 15mg of bisacodyl is highly efficacious, well tolerated, and can be used for patients who previously failed first line bowel preparations. The additional 2L of PEG in Regimen B did not improve bowel preparation and was not as well tolerated. Funding Agencies AMOSO Opportunities Grant, Pharmascence Inc.

Dataset Information

Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study.

Objectives

Methods

Results

Conclusions

Trial registration

Publications

Impact of the quality of bowel cleansing on the efficacy of colonic cancer screening: a prospective, randomized, blinded study.

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