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Randomized Controlled Trial
The efficacy of Enhanced Recovery after Surgery (ERAS) for elderly patients with intertrochanteric fractures who received surgery: study protocol for a randomized, blinded, controlled trial.
- Mengchen Yin, Yinjie Yan, Zhaoxiang Fan, Niankang Fang, Hongbo Wan, Wen Mo, and Xuequn Wu.
- Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
- J Orthop Surg Res. 2020 Mar 5; 15 (1): 91.
BackgroundIntertrochanteric 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/DesignWe 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.DiscussionAlthough 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.Trial RegistrationRegistered on 12 October 2019. Trial number is ChiCTR1900026487.
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