Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
J Orthop Surg Res. 2020 Mar 5;15(1):91. doi: 10.1186/s13018-020-01586-w.
Intertrochanteric fracture (ITF) is increasing with the rapid increase in the aging population, often causes a high mortality rate in old patients and increases the economic burden of the family and society. ERAS (Enhanced Recovery after Surgery) is a powerful guarantee for patients to accelerate their recovery after surgery. TCM (traditional Chinese medicine) promotes repair of injured tissues and eliminates traumatic aseptic inflammation. Therefore, this prospective randomized controlled clinical trial aims to evaluate the clinical effect of the evidence-based ERAS pathway of integrating TCM with western medicine on perioperative outcomes in ITF patients undergoing intramedullary fixation and provide reliable evidence-based data for applying the program to clinical practice.
METHODS/DESIGN: We will conduct a prospective randomized, blinded, controlled trial to compare the effectiveness of ERAS care pathway with traditional care pathway and to investigate whether the ERAS care pathway can improve the perioperative outcome in ITF patients undergoing intramedullary fixation. A total of 60 patients with ITF will be enrolled and treated with the two care pathway, respectively. Length of stay, economic indicators, Harris score, VAS score, time to get out of bed, 30-day readmission rates, postoperative transfusion rates, discharge to home, and mortality will be evaluated. Any signs of acute adverse reactions will be recorded at each visit during treatment.
Although an evidence-based process using the best available literature and Delphi expert-opinion method has been used to establish an ERAS pathway of integrating TCM with western medicine, there is a lack of consensus about its effectiveness. This trial will provide convincing evidence about the effect of ERAS pathway.
Registered on 12 October 2019. Trial number is ChiCTR1900026487.
随着人口老龄化的快速增长，股骨转子间骨折（ITF）的发病率也在不断增加，常导致老年患者死亡率较高，并增加了家庭和社会的经济负担。加速康复外科（ERAS）是患者术后快速康复的有力保障。中医（TCM）促进损伤组织的修复，消除创伤性无菌性炎症。因此，本前瞻性随机对照临床试验旨在评估中西医结合 ERAS 路径对髓内固定治疗 ITF 患者围手术期结局的临床效果，为该方案在临床实践中的应用提供可靠的循证数据。
方法/设计：我们将进行一项前瞻性随机、盲法、对照临床试验，比较 ERAS 护理路径与传统护理路径的效果，并探讨 ERAS 护理路径是否能改善髓内固定治疗 ITF 患者的围手术期结局。共纳入 60 例 ITF 患者，分别采用两种护理路径进行治疗。评估指标包括住院时间、经济指标、Harris 评分、VAS 评分、下床时间、30 天再入院率、术后输血率、出院回家率和死亡率。在治疗期间的每次就诊时，都会评估是否有任何急性不良反应的迹象。
虽然已经使用基于最佳可用文献和 Delphi 专家意见的循证方法来制定中西医结合 ERAS 路径，但关于其有效性仍缺乏共识。本试验将提供关于 ERAS 路径效果的令人信服的证据。
于 2019 年 10 月 12 日注册。试验编号为 ChiCTR1900026487。
