Durnal Ann M, Maxwell Terri R, Kiran Ravi P, Kommala Dheerendra
Independent Nurse Consultant, USA.
Br J Nurs. 2011;20(16):S4-6, S8-11. doi: 10.12968/bjon.2011.20.Sup9.S4.
This international, phase III, 215-day, open-label, non-randomized, multicentre study assessed the safety and efficacy of 12-hour wear times with a novel colostomy continence control device in participants with end colostomies. Study stages were usual pouching (21 days), wafer transition (14 days), device 'ramp-up' for 4, 6, and 8 hours (21 days), and 12-hour device wear (159 days). Of the 78 participants enrolled, 66 wore at least one device, and 45 completed treatment. Median device wear time was 11 hours per day during the final stage. Adverse events were reported by 12%, 7%, and 56% of participants during the usual pouching stage (0.01 events per participant per day), wafer transition stage, and device-wear stages (0.01 events per participant per day), respectively. No detrimental effects were seen on stoma vascularity or the normal gastrointestinal flora. The daily leakage-free rate was 0.89 for any leakage and 0.93 for type 2 leakage (e.g. not contained under the wafer). Most participants (87%) rated the ability of the device to restore continence as 'good' or 'very good'. Overall, the study showed that the continence control device was safe and effective for wear times up to 12 hours per day in colostomy patients.
这项国际多中心、三期、为期215天的开放标签、非随机研究评估了一种新型结肠造口术控便装置在结肠造口患者中12小时佩戴时间的安全性和有效性。研究阶段包括常规造口袋佩戴（21天）、造口袋过渡（14天）、装置4小时、6小时和8小时的“增加佩戴时间”（21天）以及12小时佩戴装置（159天）。在登记的78名参与者中，66人至少佩戴了一种装置，45人完成了治疗。在最后阶段，装置的中位佩戴时间为每天11小时。在常规造口袋佩戴阶段（每位参与者每天0.01次不良事件）、造口袋过渡阶段和装置佩戴阶段（每位参与者每天0.01次不良事件），分别有12%、7%和56%的参与者报告了不良事件。未观察到对造口血管或正常胃肠道菌群有不利影响。对于任何渗漏，每日无渗漏率为0.89，对于2型渗漏（例如，造口袋下未收集到的渗漏），每日无渗漏率为0.93。大多数参与者（87%）对装置恢复控便能力的评价为“良好”或“非常好”。总体而言，该研究表明，这种控便装置对于结肠造口患者每天长达12小时的佩戴时间是安全有效的。
