Multicentre study of a continent colostomy plug

A multicentre clinical study was carried out to assess the performance of a new disposable device, the Conseal 1-Piece, for colostomy control and continence. Forty-three patients were studied; none had any complication at the stoma. The time elapsed since surgery and the condition of the stoma and surrounding skin were recorded. The new product was compared with the patients usual colostomy bag, studying the following parameters: ease of application, reliability, leakage, confidence, ease of removal, adhesion and comfort. Thirty-seven patients completed the study. No complications arose, and complete faecal continence was obtained with 71.1 per cent of applications. The plug was kept in position for a mean of 11.5 h and a normal stoma bag was used for the remainder of the day. Of the 37 patients who completed the trial, 26 preferred the Conseal 1-Piece to a colostomy bag. In this preliminary study the device was easy to apply, involved no major complications and provided a high degree of continence. This product deserves further study because of its simplicity of use. However, research to improve the level of continence should continue.