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      Prospective single-blinded single-center randomized controlled trial of Prep Kit-C and Moviprep: Does underlying inflammatory bowel disease impact tolerability and efficacy?

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          Abstract

          BACKGROUND

          Colonoscopy remains the gold standard for detection of colonic disease. An optimal evaluation depends on adequate bowel cleansing. Patients with inflammatory bowel disease (IBD), require frequent endoscopic assessment for both activity and dysplasia assessment. Two commonly used bowel preparations in Australia are Prep Kit-C (Pc) and Moviprep (Mp). Little is known about tolerability, efficacy and safety of split protocols of Mp and Pc in both IBD and non-IBD patients.

          AIM

          To primary aim was to compare the tolerability, efficacy and safety of split protocols of Mp and Pc in patients having a colonoscopy. The secondary aim was to compare the efficacy, tolerability and safety of either preparation in patients with or without IBD.

          METHODS

          Patients were randomized to Pc or Mp bowel preparation. Patients completed a questionnaire to assess tolerability. Efficacy was assessed using the Ottawa Bowel Preparation Score. Serum electrolytes and renal function were collected one week prior to colonoscopy and on the day of colonoscopy.

          RESULTS

          Of 338 patients met the inclusion criteria. Of 168 patients randomized to Mp and 170 to Pc. The efficacy of bowel preparation (mean Ottawa Bowel Preparation Score) was similar between Mp (5.4 ± 2.4) and Pc (5.1 ± 2.1) ( P = 0.3). Mean tolerability scores were similar in Mp (11.84 ± 5.4) and Pc (10.99 ± 5.2; P = 0.17). 125 patients had IBD (73 had Crohn’s Disease and 52 had Ulcerative colitis). Sixty-four IBD patients were allocated to Mp and 61 to Pc. In non-IBD patients, 104 were allocated to Mp and 109 to Pc. The mean tolerability score in the IBD group was lower than the non-IBD group (mean tolerability scores: IBD: 10.3 ± 5.1 and non-IBD: 12.0 ± 5.3; P = 0.01). IBD patients described more abdominal pain with Mp when compared with Pc; (Mp: 5.7 ± 4.4 vs Pc: 3.6 ± 2.6, P = 0.046). Serum magnesium level increased with Pc compared with Mp in all patients (mean increase in mmol/L: Mp: 0.03 ± 0.117 and Pc: 0.11 ± 0.106; P < 0.0001).

          CONCLUSION

          In this study, the efficacy, tolerability and safety of Mp and Pc were similar in all patients. However, patients with IBD reported lower tolerability with both preparations. Specifically, IBD patients had more abdominal pain with Mp. These results should be considered when recommending bowel preparation especially to IBD patients.

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          Most cited references25

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          Quality indicators for colonoscopy.

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            Validation of a new scale for the assessment of bowel preparation quality.

            Bowel preparation quality scales are used to document the superiority of one preparation regime vs. another. The validity and reliability of these scales are not routinely stated in reports of studies in which the scales are used. A new colonoscopy bowel preparation scale (the Ottawa bowel preparation scale) was developed and validated prospectively. Ninety-seven consecutive patients undergoing elective outpatient colonoscopy were entered into the study. The quality of the bowel preparation was assessed independently by two investigators who used the Ottawa scale, and the only other validated scale (Aronchick scale) that could be identified. The interobserver agreement and reliability of each scale was assessed by the Pearson correlation coefficient (r), the intraclass correlation coefficient, and regression analysis. The Pearson correlation coefficients were, respectively, 0.89 and 0.62 for the Ottawa and Aronchick scales (p<0.001). The values for the kappa statistic, an intraclass correlation coefficient measuring agreement over and above chance agreement, were, respectively, 0.94 and 0.77 (p<0.001). Linear regression analysis, mapping the line best describing the scatter of scores by raters, for the Ottawa scale revealed a slope of the line of 0.93 and a y intercept of 0.10. The Aronchick scale revealed a slope of 0.65 and a y intercept of 0.46. The Ottawa scale thus was closer to an identity line comparing raters (i.e., closer to a line with slope of 1.00 and y intercept of 0.00). The Ottawa scale demonstrated a right colon kappa (intraclass correlation coefficient) of 0.92: 95% CI[0.88, 0.95], a mid colon kappa (intraclass correlation coefficient) of 0.88: 95% CI[0.82, 0.92], and a rectosigmoid kappa (intraclass correlation coefficient) of 0.89: 95% CI[0.83, 0.92]. The Ottawa scale was validated prospectively and demonstrates high interobserver agreement and reliability, whether used as a total score or for individual colon segments.
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              Validated Scales for Colon Cleansing: A Systematic Review.

              Bowel cleanliness is a critical determinant of colonoscopy quality, mandating its standardized assessment, yet bowel preparation scales have been variably validated. The objective of this study was to assess validity and reliability of existing bowel preparation scales.
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                Author and article information

                Contributors
                Journal
                World J Gastroenterol
                World J Gastroenterol
                WJG
                World Journal of Gastroenterology
                Baishideng Publishing Group Inc
                1007-9327
                2219-2840
                21 March 2021
                21 March 2021
                : 27
                : 11
                : 1090-1100
                Affiliations
                Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast, 4215, Queensland, Australia. wmoh6298@ 123456uni.sydney.edu.au
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia
                Ingham Institute Applied Medical Research, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia
                Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney 2170, New South Wales, Australia
                South West Sydney Clinical School, University of New South Wales, Sydney 2170, New South Wales, Australia
                Ingham Institute Applied Medical Research, Sydney 2170, New South Wales, Australia
                Author notes

                Author contributions: Mohsen W and Williams AJ collected data, compiled data, blinded endoscopist (fellow), recruited patients from clinic, organized spreadsheet, developed tables, liaised wrote the manuscript; Wark G collected data and developed the figures; Sechi A inflammatory bowel disease nurse consultant who assisted with education, recruitment of patients and answering patient concerns during the trial process; Koo JH blinded assisted with manuscript review, study design and statistical analysi; Xuan W is statistician from the Ingham institute who assisted with the statistical analysis; Bassan M assisted with the review of the manuscript; Ng W recruited patients, assisted with study design and assisted with review process and manuscript development; Connor S developed study design and end points for the study, applied for ethics approval, assisted with the development of the manuscript.

                Corresponding author: Waled Mohsen, FRACP, Gastroenterologist, Department of Digestive Diseases, Gold Coast University Hospital, Gold Coast 4215, Queensland, Australia. wmoh6298@ 123456uni.sydney.edu.au

                Article
                jWJG.v27.i11.pg1090
                10.3748/wjg.v27.i11.1090
                7985733
                33776375
                d3568ef9-f18f-46c7-88c8-891592da79c0
                ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.

                This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/

                History
                : 1 November 2020
                : 11 January 2021
                : 7 March 2021
                Categories
                Clinical Trials Study

                bowel preparation,inflammatory bowel disease,tolerability,efficacy,moviprep,prep kit-c

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