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      Real-life conditions of use of sodium phosphate tablets for colon cleansing before colonoscopy

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          Abstract

          Background and study aims: The purpose of this study was to describe the real-life conditions of use, efficacy, safety, and acceptability of sodium phosphate (NaP) tablets for colon cleansing in routine medical practice in France.

          Patients and methods: A total of 996 patients undergoing bowel preparation were enrolled by 108 gastroenterologists in this observational, longitudinal, prospective, multicenter study. The conditions of use of NaP tablets were assessed with a composite endpoint, which included six criteria for patient compliance with the recommended administration scheme and a criterion for the absence of contraindications to NaP use.

          Results: Adequate use of NaP was reported for 75.1 % of the patients. The main reasons for misuse were a smaller fluid intake than expected with a dose of 4 tablets and noncompliance with age-related contraindications. The quality of cleansing was satisfactory: the Boston Bowel Preparation Scale (BBPS) total score was 7 or higher in 75.4 % of the patients. Gastroscopy associated with colonoscopy in 38.9 % of the patients revealed gastric lesions, which were considered as possibly related to the use of NaP tablets in 10.3 % of them. Vomiting occurred in 9.8 % of the patients, and 0.6 % discontinued bowel preparation after an adverse event. No electrolyte disorders or renal impairment was reported, even if not systematically sought. The acceptability of the NaP tablets was high, particularly among patients who previously had undergone other methods of bowel preparation.

          Conclusions: Despite being defined according to strict criteria, adequate use of NaP tablets was observed in a high percentage of patients. The quality of colon cleansing and the safety and acceptability of NaP tablets were satisfactory and consistent with data from randomized clinical studies.

          Most cited references12

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          Comprehensive validation of the Boston Bowel Preparation Scale.

          The Boston Bowel Preparation Scale (BBPS) is a novel bowel cleanliness rating scale that has undergone partial validation previously. To fully validate the BBPS and assess the ease of its dissemination. Observational study. Various endoscopy units worldwide. Endoscopists. Video recordings of colonoscopies with varying degrees of cleanliness were viewed twice by gastroenterologists at 1 medical center. For each video, participants assigned segment and total BBPS scores. Endoscopists worldwide were also surveyed about their experience with the BBPS after viewing an instructional video. Intraclass correlation coefficients and weighted κ values assessed inter- and intrarater reliability, respectively. The BBPS was used among 983 patients undergoing screening colonoscopy. The BBPS demonstrated near-perfect interrater reliability (intraclass correlation coefficient = 0.91) and substantial intrarater reliability (weighted κ = 0.78; 95% CI, 0.73-0.84). Among 983 colonoscopies, right and left colon segment scores of 2 or 3 had a multivariate odds ratio of 1.60 (95% CI, 1.01-2.55) and 2.58 (95% CI, 1.34-4.98), respectively, for polyp detection compared with segment scores of 0 or 1. Endoscopists from a variety of settings worldwide found the BBPS easy to implement and applicable to their patient population. Single-center reliability testing. The BBPS is a valid and reliable instrument for assessing bowel cleanliness during colonoscopy. Segment scores may represent a standardized way to determine bowel preparation adequacy. The BBPS can be easily disseminated through the use of a brief instructional video. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.
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            Systematic review: oral bowel preparation for colonoscopy.

            There are many published trials of colon cleansing regimens for colonoscopy but no clear consensus regarding relative performance. To identify high quality controlled trials comparing two or more bowel preparation regimens and to compare efficacy and tolerability. A comprehensive systematic review was carried out to identify candidate studies. Quality appraisal was carried out on all identified studies. Results were meta-analysed where possible and qualitatively compared if not. Eighty-two studies qualified for analysis. Polyethylene glycol and sodium phosphate were the most frequently investigated preparations. There was no significant efficacy difference between the two, but sodium phosphate was better tolerated. Sodium picosulphate/magnesium citrate, a commonly prescribed preparation, was investigated in four studies, with no clear benefit over other regimens demonstrated. Safety was not recognized as a problem in the randomized controlled trials. Published case series demonstrate that sodium phosphate is associated with the highest risk of clinically significant electrolyte disturbances. Shortcomings in study design limit the value of many of the studies. Based on these results, no single bowel preparation emerges as consistently superior. New preparations are required that combine better efficacy and tolerability, in addition to rigorous new validated study designs, allowing unequivocal comparisons to be made.
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              Which is the optimal bowel preparation for colonoscopy - a meta-analysis.

              To assess which bowel preparation agent is most effective. A search of randomized trials between January 1990 and July 2005 was obtained, using MEDLINE and PubMed databases, and the Cochrane Central Register of Controlled Trials. Meta-analysis was performed using the Forest plot review. Sodium phosphate (NaP) was more effective in bowel cleansing than polyethylene glycol (PEG) - odds ratio 0.75 (95%CI: 0.65-0.88; P = 0.0004); and sodium picosulphate (SPS) - odds ratio 0.52 (95%CI: 0.34-0.81; P = 0.004). PEG and SPS were comparable in bowel cleansing ability, odds ratio 1.69 (95%CI: 0.92-3.13; P = 0.09). NaP was more easily completed by patients compared to PEG, odds ratio 0.16 (95%CI: 0.09-0.29; P < 0.00001). More patients were able to complete SPS than PEG, but this was not statistically significant - odds ratio 0.56 (95%CI: 0.28-1.13; P = 0.11). NaP and PEG were comparable in terms of adverse events, odds ratio 0.98 (95%CI: 0.82-1.17; P = 0.81), although NaP resulted in more asymptomatic hypokalaemia and hyperphosphataemia. NaP and SPS appeared to have similar incidence of adverse events. PEG resulted in more adverse events than SPS, odds ratio 3.82 (95%CI: 1.60-9.15; P = 0.003). NaP was more effective in bowel cleansing than PEG or SPS and was comparable in terms of adverse events. Patients have more difficulty completing PEG than NaP and SPS. Biochemical changes associated with a small-volume preparation like NaP, albeit largely asymptomatic, mandate caution in patients with cardiovascular or renal impairment.
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                Author and article information

                Journal
                Endosc Int Open
                Endosc Int Open
                10.1055/s-0034-1377934
                Endoscopy International Open
                © Georg Thieme Verlag KG (Stuttgart · New York )
                2364-3722
                2196-9736
                August 2015
                05 May 2015
                : 3
                : 4
                : E346-E353
                Affiliations
                [1 ]CHI de Créteil, Service d’Hépato-gastroentérologie, Créteil, France
                [2 ]Hôpital de la Timone, Service de Gastroentérologie, Marseille, France
                [3 ]GHI Le Raincy-Montfermeil, Service de Gastroentérologie, Montfermeil, France
                [4 ]Clinique Saint-Jean Languedoc, Service de Gastroentérologie et Hépatologie, Toulouse, France
                [5 ]Service de Néphrologie, Hôpital de la Pitié-Salpêtrière, Paris, France
                [6 ]Département de Pharmacovigilance, Mayoly-Spindler, Chatou, France.
                Author notes
                Corresponding author Hervé Hagège, MD CHI de Créteil Service d’Hépato-Gastroentérologie CréteilFrance+33-1-45-17-54-76 herve.hagege@ 123456chicreteil.fr
                Article
                10.1055/s-0034-1391847
                4554515
                0d5fb8de-752f-43ba-a100-24a93a6fe77b
                © Thieme Medical Publishers
                History
                : 12 January 2015
                : 21 January 2015
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