未来多中心观察研究的可行性 - - 糖尿病是ERAS关节关节整形手术的风险因素吗?
Luma Mahmoud Issa1,2, Christoffer Calov Jørgensen3,4, Sten Madsbad5
1Department of Anaesthesia and Intensive Care, Hvidovre University Hospital, Kettegård Alle 30, Hvidovre, 2650, Denmark. luma.mahmoud.issa@regionh.dk.
Pilot and feasibility studies
|December 12, 2025
概括
这项研究表明,在进行关节或膝关节置换手术的糖尿病患者的详细数据收集在手术后增强恢复 (ERAS) 计划中是可行的. 数据的高度完整性支持进一步研究糖尿病管理.
科学领域:
- 整形外科手术 整形外科手术
- 内分泌学 在内分泌学.
- 临床研究方法论 临床研究方法论
背景情况:
- 糖尿病是一种已知的手术风险因素,但最优的外科手术期间管理策略,特别是在手术后增强恢复 (ERAS) 计划中,需要进一步调查.
- 现有的术后糖尿病管理指南不一致,强调需要更多数据,特别是关于ERAS原则的整合.
- 启动了一项前性观察性多中心研究,以解决有关糖尿病患者接受部和膝盖关节整形手术的知识差距.
研究的目的:
- 评估在ERAS计划中对接受部和膝盖关节整形手术的糖尿病患者进行详细,前性,多中心观察性研究的可行性.
- 在现实临床环境中评估数据的完整性和招聘成功.
- 为一项更大规模的研究奠定基础,研究糖尿病及其管理对手术结果的影响.
主要方法:
- 该研究涉及从2022年10月到2024年1月在丹麦八个公共关节整形中心收集前性数据.
- 数据包括抗高血糖药物的使用,手术前HbA1c水平,手术前糖尿病管理细节,停留时间 (LOS) 和接受全部 (THA),全膝盖 (TKA) 或单隔膝盖 (UKA) 关节整形手术的患者的再入院率.
- 根据数据的完整性和患者招募率来评估可行性.
主要成果:
- 这项研究成功招募了1007名糖尿病患者,他们接受了各种部和膝盖关节整形手术.
- 对抗高血糖药物 (100%),LOS (100%) 和90天随访 (99%) 等关键指标的数据完整性很高.
- 术前HbA1c评估和术后糖尿病管理数据显示完成率很好 (分别增加到96%和98%).
结论:
- 这些发现表明,在ERAS部和膝关节关节整形设置中,成功实施了针对糖尿病患者的前性多中心数据收集框架.
- 关键数据点的高合规率 (≥94%) 证实了收集的数据的质量和完整性.
- 该研究的可行性和强大的招生人数为主要研究提供了坚实的基础,旨在招募2000名患者,以分析糖尿病对结果的影响.
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