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.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-08-24 DOI:10.1186/s13063-024-08227-1
Jing Chen, Lishuang Chen, Xueqin Hu, Zengna Xing, Yuhui Sun, Fabin Lin, Rui Wang, Chunmei Chen, Yanjuan Lin
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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.

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硬膜外髓内脊柱肿瘤围手术期加强康复与常规护理的临床评估:多中心随机对照试验的研究方案。
背景:本随机临床试验方案旨在研究增强型术后恢复方案(ERAS)与传统围手术期护理方案在硬膜外脊柱肿瘤患者中的疗效比较:研究对象包括 180 名年龄在 18-80 岁之间的患者,他们被随机分配到两组: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被告知分组情况,但患者本人对干预措施保持盲目。主要结果指标是评估功能状态的卡诺夫斯基表现量表(Karnofsky Performance Scale)评分。次要结果包括日本骨科协会量表、数字疼痛评分量表、术后住院时间、尿道导管插入时间、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:该研究方案提供了一种结构化的方法来评估ERAS在硬膜外肿瘤患者围手术期的潜在益处,旨在改善患者预后和整体护理效率:本研究已在中国临床试验注册中心注册(项目编号:ChiCTR2200063347)。注册时间:2022年9月5日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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