Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Sorbonne Université, Paris, France.
Urology, GRC no. 5, Predictive Onco-Urology, AP-HP, Hôpital Pitié-Salpêtrière, Sorbonne University, Paris, France.
Colorectal Dis. 2023 Jan;25(1):128-143. doi: 10.1111/codi.16343. Epub 2022 Oct 8.
A stoma exposes patients to several complications which could impair their quality of life (QoL). In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the activities of home health providers, meeting a need for patient follow-up and companionship. International studies have demonstrated the impact of the stoma therapist (ST) follow-up on the improvement of an ostomy patient's QoL. However, the impact of home stoma nurse management has not been analysed. In this context we would like to assess the added value on health-related QoL from the enhanced follow-up of ostomy patients by STs.
This is a randomized, controlled, open, national and multicentre trial (12 centres) which includes patients with an ostomy who benefit from either standard follow-up or from an enhanced and personalized follow-up with, in particular, regular consultations with an ST after discharge. The primary end-point is the 3-month QoL score obtained from the Stoma-QoL questionnaire. The secondary end-points are satisfaction of the care, comparison of QoL scores (Stoma-QoL and EuroQuol EQ-5D) and the economic gains by calculating the consumption of resources between the two arms. There will be a modified intention-to-treat analysis with 6-month follow-up in both study arms.
The StomaCare trial will be the first randomized controlled study in France to evaluate the impact on QoL of an enhanced follow-up at home of ostomy patients by an ST.
造口使患者面临多种并发症，这些并发症可能会影响他们的生活质量（QoL）。在过去十年中，法国的造口治疗市场发生了变化，家庭健康提供者的活动显著增加，以满足患者随访和陪伴的需求。国际研究已经证明了造口治疗师（ST）随访对改善造口患者生活质量的影响。然而，家庭造口护士管理的影响尚未得到分析。在这种情况下，我们希望评估 ST 加强对造口患者的随访对健康相关生活质量的增值作用。
这是一项随机、对照、开放、全国性和多中心试验（12 个中心），包括受益于标准随访或强化个性化随访的造口患者，特别是在出院后定期与 ST 进行咨询。主要终点是通过造口生活质量问卷（Stoma-QoL）获得的 3 个月 QoL 评分。次要终点是护理满意度、QoL 评分（造口生活质量和 EuroQuol EQ-5D）的比较，以及通过计算两个治疗组之间的资源消耗来计算经济收益。将进行改良意向治疗分析，并在两个研究组中进行 6 个月随访。
StomaCare 试验将是法国第一项评估 ST 在家中对造口患者进行强化随访对生活质量影响的随机对照研究。
