目的:这项研究的目的是分析与使用旨在预防造口旁疝(PSH)的实验原型相关的并发症和问题。造口术中最常见的并发症之一。
方法:单中心,非比较性,进行了概念验证的实验原型的介入性试验研究,该实验原型设计用于与腹部加压粘合剂结合使用以防止PSH。“疝预防造口固定装置”(专利P201531826)是一种半刚性造口保护器,与压缩粘合剂一起使用。它旨在适应不同品牌的标准造口袋的尺寸,用于传输,以本地化的方式,在不对收集袋施加压力的情况下,来自造口周围区域中的压缩粘合剂的支撑件。主要结果指标是疗效,安全,和患者用户的意见/看法。
结果:对10例患者进行了为期12个月的研究。平均年龄为61岁(±11.59),70%(7)为男性,80%(8)结肠直肠癌造口,90%(9)进行了计划的手术,80%(8)进行了结肠造口术。
结果:HPE的发生率为10%(1)。
结果:没有参与者经历疼痛,不适,瘙痒,刺痛,泄漏,取袋,对成分过敏,或由于摩擦或压力而对造口或造口周围皮肤造成伤害。90%(n=9)被认为对装置“非常满意”或“满意”。
结论:在医疗保健专业人员和最终用户之间合作设计的创新设备已被证明可以安全有效地减少所研究的造口症组的PSH。
OBJECTIVE: The aim of this study was to analyse the complications and problems associated with the use of an experimental prototype designed for the prevention of parastomal hernia (PSH), one of the most frequent complications in ostomates.
METHODS: A single-centre, non-comparative, proof-of-concept interventional pilot study of an experimental prototype designed to be used in conjunction with an abdominal compression binder to prevent PSH was conducted. The \"Ostomy Fixation Device for Hernia Prevention\" (patent P201531826) is a semi-rigid ostomy protector, to be used in conjunction with a compression binder. It is designed to adapt to the dimensions of standard ostomy bags from different brands and serves to transmit, in a localised manner, the support coming from the compression binder in the peristomal area without putting pressure on the collection bag. The main outcome measures were efficacy, safety, and patient-users\' opinion/perception.
RESULTS: Ten patients were studied for 12 months. Mean age was 61 years (± 11.59), 70% (7) were male, 80% (8) ostomised for colorectal cancer, 90% (9) underwent planned surgery and 80% (8) had a colostomy.
RESULTS: the incidence of HPE was 10% (1).
RESULTS: no participant experienced pain, discomfort, itching, stinging, leakage, pouch detachment, allergy to components, or injury to the stoma or peristomal skin due to rubbing or pressure. 90% (n = 9) were considered \"very satisfied\" or \"satisfied\" with the device.
CONCLUSIONS: An innovative device designed in collaboration between healthcare professionals and end-users has been shown to be safe and effective in reducing PSH in the group of ostomates studied.