Observational multicentric study to evaluate efficacy, adverse effects and acceptance of bowel cleansing prior to colonoscopy withsodium picosulfate / magnesium citrate formulation CitraFleet((R))

摘要

The various efficient methods available for bowel preparation prior to colonoscopy differ in patient acceptance. Combining the laxative sodium picosulfate with hyperosmotic magnesium citrate, used in this study in the formulation CitraFleet((R)), allows the uptake of the purgative substances as a solution of low volume. This observational study with 737 patients evaluated efficacy of bowel preparation, potential side or adverse effects and patient acceptance of this medicinal product when used by resident physicians in Germany. Colon cleansing with CitraFleet((R)) was considered very good to sufficient in 95.2% of the patients and inadequate in only 4.8%. In 75% of the colonoscopies, bowel preparation was rated very good or good. Compared to the standard regimen of two portions taken the day before endoscopy, cleaning efficacy was better when patients received one of the doses on the morning of the day of colonoscopy. The quality of bowel preparation was rated lower by gastroenterologists without any prior experience with sodium picosulfate/magnesium citrate. The overall assessment of the colon cleansing procedure by the 76 participating physicians was very positive and patient acceptance was also very high which can be considered a clear advantage over alternative methods. Efficacy of colon cleansing with CitraFleet((R)) was not substantially affected by typical deviations from the recommended standard procedure, emphasizing the robustness of the method. Only one of the patients reported a mild adverse effect potentially caused by the cleansing agents.