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硬膜外髓外脊髓肿瘤围手术期强化康复与常规护理的临床评价:一项多中心随机对照试验研究方案。

Clinical evaluation of enhanced recovery versus conventional care in the perioperative period for intradural extramedullary spinal tumors: a study protocol for a multicenter, randomized controlled trial.

机构信息

Department of Neurosurgery Nursing, Fujian Medical University Union Hospital, Fuzhou, 350001, China.

Changde Hospital, Xiangya School of Medicine, Central South University, Hunan, 415099, China.

出版信息

Trials. 2024 Aug 24;25(1):561. doi: 10.1186/s13063-024-08227-1.

Abstract

BACKGROUND

This randomized clinical trial protocol aimed to investigate the comparative efficacy of an enhanced recovery after surgery (ERAS) protocol versus traditional perioperative care programs in patients with intradural extramedullary spinal tumors.

METHODS

The study included 180 patients aged 18-80 years, who were randomly assigned to two groups: Group A receiving traditional perioperative care and Group B receiving accelerated rehabilitation perioperative care. The nurse responsible for patient care was informed of the group assignment, but the patients themselves remained blinded to the intervention. The primary outcome measure was the Karnofsky Performance Scale score, which assessed functional status. The secondary outcomes included the Japanese Orthopedic Association Scale, Numeric Pain Rating Scale, length of postoperative hospital stay, duration of urethral catheterization, patient satisfaction questionnaire, and complication rates. Follow-up assessments were conducted telephonically 1 month, 3 months, and 6 months after the surgery.

DISCUSSION

This study protocol provided a structured approach to assess the potential benefits of ERAS during the perioperative period for patients with intradural extramedullary tumors, aiming to improve patient outcomes and overall care efficiency.

TRIAL REGISTRATION

This study has been registered with the China Clinical Trials Registry (Project No: ChiCTR2200063347). Registered on September 5 2022.

摘要

背景

本随机临床试验方案旨在探究强化术后康复(ERAS)方案与传统围手术期护理方案在硬脊膜外髓外肿瘤患者中的比较疗效。

方法

本研究纳入了 180 名年龄在 18-80 岁之间的患者,将其随机分为两组:A 组接受传统围手术期护理,B 组接受加速康复围手术期护理。负责患者护理的护士了解分组情况,但患者本人对干预措施保持盲态。主要结局指标是卡诺夫斯基表现量表评分,用于评估功能状态。次要结局指标包括日本矫形协会量表、数字疼痛评分量表、术后住院时间、导尿管留置时间、患者满意度问卷和并发症发生率。术后 1 个月、3 个月和 6 个月通过电话进行随访评估。

讨论

本研究方案提供了一种结构化的方法来评估强化康复方案在硬脊膜外髓外肿瘤患者围手术期的潜在益处,旨在改善患者的预后和整体护理效率。

试验注册

本研究已在中国临床试验注册中心(注册号:ChiCTR2200063347)注册。注册日期为 2022 年 9 月 5 日。

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