Codina Cazador A, Piñol M, Marti Rague J, Montane J, Nogueras F M, Suñol J
Department of Surgery, Dr Josef Trueta Hospital, Gerona, Spain.
Br J Surg. 1993 Jul;80(7):930-2. doi: 10.1002/bjs.1800800748.
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.
开展了一项多中心临床研究，以评估一种新型一次性装置Conseal 1-Piece用于结肠造口控制和大便失禁的性能。研究了43例患者；造口均未出现任何并发症。记录了手术以来的时间以及造口和周围皮肤的状况。将该新产品与患者常用的结肠造口袋进行比较，研究以下参数：应用便利性、可靠性、渗漏情况、信心、移除便利性、粘附性和舒适度。37例患者完成了研究。未出现并发症，71.1%的应用实现了完全大便失禁。塞子平均保持在位11.5小时，其余时间使用普通造口袋。在完成试验的37例患者中，26例更喜欢Conseal 1-Piece而非结肠造口袋。在这项初步研究中，该装置易于应用，未出现重大并发症，并提供了高度的大便失禁控制。由于其使用简便，该产品值得进一步研究。然而，提高大便失禁控制水平的研究应继续进行。
