CLINICAL EVALUATION OF A NEW CONTINENT COLOSTOMY DEVICE “CONSEAL SYSTEM”

Abstract

　Multiple clinical trials of a new non-implantable disposable continent colostomy device “Conseal System” was performed on 86 colostomy patients at 14 institutions throughout Japan.The “Conseal System” was developed by Coloplast A/S of Denmark in 1984.
　As regards evaluation of the safety of this appliance,42 of the 86 patients were able to use it without difficulty and 2 patients were not evaluated. The remaining 42 patients experienced a total of 45 unwanted incidents in using the appliance but were,for the most part,slight and trivial and did not require treatment. Treatment was required in only 5 cases.
　Fourteen（14）patients were considered as withdrawn or dropouts while 72 patients were assessed for usefulness of the appliance. The mean wear-time of the plug was 10. 3 hours for nonirrigating patients whlie the mean wear-time was 17.9 hours for irrigating patients. The appliance was successful for fecal continence in 86.4％ of non-irrigating cases and 92.3％ of irrigating cases.In spite of these high figures for effective continent function,the system was evaluated as useful in 55.6％ of patients and not useful in 22.3％ of patients. This discrepancy seems attributable to fecal leakage caused by prolonged use of the plug beyond prescribed time limits,untimely change of the plug or an abrupt change of fecal consistency（loose or liquid stools）. In such instances,the plug function was not judged to be reliable.
　The results of this study seem to indicate that this device would be useful for patients who are carefully selected and trained to use the device under professional guidance.