Image Specialties, St. Joseph, Missouri 64506, USA.
Dis Colon Rectum. 2010 Oct;53(10):1422-31. doi: 10.1007/DCR.0b013e3181e5e0c4.
This study aimed to assess the safety and efficacy of a novel colostomy continence device.
This phase II, 142-day, open-label, nonrandomized, multicenter study enrolled patients who had end colostomies for ≥3 months. Study stages were usual pouching (21 days), wafer transition (14 days), and the device (107 days). During device wear, up to 8 hours per day, patients recorded the following outcomes in daily diaries: skin condition (if the wafer was changed); stoma color, moisture, and physical condition; and gastrointestinal symptoms.
Of the 26 patients enrolled, 25 wore at least one device. The device was worn on 96% of study days and a mean of 6.8 hours per day. Adverse events were reported by 1 patient during the usual pouching 21-day period, by 5 patients during the wafer transition 14-day period, and by 15 patients during the device wear 107-day period. Stoma color and moisture were within normal range on all daily assessments. The device did not affect microbiology or vascularity. During device wear, patients had no unusual gastrointestinal symptoms or odor on >99% and 80% of days, respectively. The mean number of leaks per patient-month was 1.2 with usual pouching, 4.2 with the device overall, and 2.1 during the last 3 weeks with the device, suggesting a learning curve. Approximately 65% of patients preferred the device to usual pouching at the end of study.
The novel continence device was safe and effective for up to 8 hours per day in colostomy patients.
本研究旨在评估一种新型结肠造口控便装置的安全性和有效性。
这是一项为期 142 天、开放标签、非随机、多中心的 II 期研究，招募了至少有 3 个月结肠造口术的患者。研究阶段包括常规造口袋使用（21 天）、底盘转换（14 天）和装置使用（107 天）。在每天不超过 8 小时的装置佩戴期间，患者每天在日记中记录以下结果：皮肤状况（如果更换底盘）；造口颜色、湿度和生理状况；以及胃肠道症状。
在 26 名入组患者中，25 名至少佩戴了一个装置。该装置每天佩戴 96%的时间，平均每天佩戴 6.8 小时。在常规造口袋使用的 21 天期间，1 名患者报告了 1 起不良事件，在底盘转换的 14 天期间，5 名患者报告了 5 起不良事件，在装置使用的 107 天期间，15 名患者报告了 15 起不良事件。所有日常评估中，造口颜色和湿度均在正常范围内。该装置不影响微生物群或血管生成。在装置佩戴期间，患者在>99%和 80%的天数分别没有异常的胃肠道症状或异味。在装置使用期间，每位患者的月漏便次数为 1.2 次，总的漏便次数为 4.2 次，在装置使用的最后 3 周漏便次数为 2.1 次，表明存在学习曲线。大约 65%的患者在研究结束时更喜欢该装置而不是常规造口袋。
在结肠造口患者中，新型控便装置每天安全使用长达 8 小时是有效且安全的。
