Consultant Colorectal Surgeon and Lead, Newcastle Centre for Bowel Disease Research Group, Newcastle Hospitals and Newcastle University, Newcastle upon Tyne, UK.
Clinical Nurse Specialist, Duke University Health System, Durham, North Carolina, USA.
Br J Nurs. 2023 Mar 23;32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4.
More than 90% of people with an ostomy worry about leakage, with associated high rates of psychological morbidity.
To assess the performance of a novel digital ostomy leakage notification system in subjects with faecal stomas who experience and worry about leakage.
A prospective, single-arm, pilot study (ClinicalTrials.gov: NCT04894084) with 25 subjects testing the product for 21 days. Subjects completed questionnaires at baseline and termination of study evaluating leakage episodes, leakage worry and quality of life (QoL).
Mean age was 56 years, 60% had an ileostomy, and 40% were females. Mean episodes of leakage outside the baseplate decreased significantly from 2.8 to 0.5 episodes after 21 days' use of the test product (<0.001), worry about leakage decreased significantly (<0.001) and QoL improved.
The findings indicate strong improvements to emotional health with the test product, driven by reductions in leakage incidents outside baseplate and in users' worry about leakage.
超过 90%的造口患者担心造口漏液，这与较高的心理发病率有关。
评估一种新型数字造口漏液通知系统在经历和担心漏液的粪便造口患者中的性能。
一项前瞻性、单臂、初步研究（ClinicalTrials.gov：NCT04894084），共纳入 25 名受试者，对产品进行了 21 天的测试。受试者在基线和研究结束时完成评估漏液发作、漏液担忧和生活质量（QoL）的问卷。
平均年龄为 56 岁，60%的患者为回肠造口，40%为女性。使用测试产品 21 天后，底盘外漏液的平均发作次数从 2.8 次显著减少到 0.5 次（<0.001），漏液担忧显著减少（<0.001），生活质量得到改善。
研究结果表明，测试产品对情绪健康有显著的改善作用，这得益于底盘外漏液事件和使用者对漏液的担忧的减少。
