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择期全髋关节和膝关节置换术围手术期强化康复方案的术后结局。POWER.2研究:一项前瞻性、多中心、观察性队列研究的研究方案。

Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol in Elective Total Hip and Knee Arthroplasty. POWER.2 Study: Study Protocol for a Prospective, Multicentre, Observational Cohort Study.

作者信息

Ripollés-Melchor Javier, Abad-Motos Ane, Logroño-Egea Margarita, Aldecoa César, García-Erce José Antonio, Jiménez-López Ignacio, Cassinello-Ogea Concepción, Marín-Peña Oliver, Ferrando-Ortolá Carlos, de la Rica Alejandro Suárez, Gómez-Ríos Manuel A, Sánchez-Martín Rubén, Abad-Gurumeta Alfredo, Casans-Francés Rubén, Mugarra-Llopis Ana, Varela-Durán Marina, Longás-Valién Javier, Ramiro-Ruiz Álvaro, Cuellar-Martínez Ana B, Ramírez-Rodríguez José M, Calvo-Vecino José M

机构信息

Department of Anesthesia and Critical Care, Infanta Leonor University Hospital, Madrid, Spain.

Universidad Complutense de Madrid, Madrid, Spain.

出版信息

Turk J Anaesthesiol Reanim. 2019 Jun;47(3):179-186. doi: 10.5152/TJAR.2019.87523. Epub 2019 Jan 24.

Abstract

OBJECTIVE

The number of indications for total hip replacement (THR) and total knee replacement (TKR) surgery is increasing. Enhanced recovery after surgery (ERAS) represents the next step in the evolution of standardised care. The primary aim of this study is to measure the in-hospital 30-day medical and surgical postoperative complications rate. The study's secondary aims are to determine the length of stay, 30-day mortality rate, 30-day reoperation and readmission rates, the ERAS overall compliance and predefined ERAS individual items compliance.

METHODS

This multicentre, prospective, observational study will include adult patients (aged >18 years) undergoing elective THR and TKR surgery. Consecutive patients undergoing surgery within the 2-month data collection period will be included. Centres that offer the THR and/or TKR surgery will be eligible to participate. The data collection will be done through an online data collection form via a secure, password-protected platform at each centre with predefined data fields.

RESULTS

Ethical approval for this study has been obtained from the Comité de Ética de la Investigación de la Comunidad Autónoma de Aragón (C.P.-C.I. PI18/135; on 23 May 2018). It was prospectively registered on 27 June 2018, at www.clinicaltrials.gov with identification no. NCT03570944.

CONCLUSION

The study will be disseminated through the SPARN-RedGERM, SEDAR, GERM and through social media. Peer-reviewed publications will be published under corporate authorship, including POWER.2 Study Group and SPARN-RedGERM.

摘要

目的

全髋关节置换术(THR)和全膝关节置换术(TKR)手术的适应证数量正在增加。术后加速康复(ERAS)是标准化护理发展的下一步。本研究的主要目的是测量住院30天的医疗和手术术后并发症发生率。该研究的次要目的是确定住院时间、30天死亡率、30天再次手术率和再入院率、ERAS总体依从性以及预定义的ERAS单项依从性。

方法

这项多中心、前瞻性、观察性研究将纳入接受择期THR和TKR手术的成年患者(年龄>18岁)。在2个月数据收集期内接受手术的连续患者将被纳入。提供THR和/或TKR手术的中心将有资格参与。数据收集将通过每个中心一个受密码保护的安全平台上的在线数据收集表进行,数据字段已预先定义。

结果

本研究已获得阿拉贡自治区社区研究伦理委员会的伦理批准(C.P.-C.I. PI18/135;2018年5月23日)。它于2018年6月27日在www.clinicaltrials.gov上进行了前瞻性注册,识别号为NCT03570944。

结论

该研究将通过SPARN-RedGERM、SEDAR、GERM以及社交媒体进行传播。同行评审的出版物将以团体作者身份发表,包括POWER.2研究组和SPARN-RedGERM。

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