Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols for Arthroscopic Anterior Cruciate Ligament Reconstruction in an Ambulatory Surgery Setting

Официальное название

Evaluation of Clinical Outcomes and Feasibility of Enhanced Recovery After Surgery (ERAS) Protocols for Arthroscopic Anterior Cruciate Ligament Reconstruction in an Ambulatory Surgery Setting: A Non-randomized Controlled Trial

Обзор

The anterior cruciate ligament (ACL) is a critical component for maintaining knee stability by resisting anterior tibial translation and internal rotation. ACL rupture is one of the most common orthopedic injuries, with an estimated incidence of 70 cases per 100,000 people annually. Since its inception, arthroscopic anterior cruciate ligament reconstruction (AACLR) has proven to be the gold standard, providing excellent outcomes in terms of graft longevity, return to sports, and patient satisfaction. Modern medical trends are shifting toward day-surgery protocols, where patients are discharged within 24 hours without an overnight stay. This model is identified as a major factor in enhancing the quality of postoperative recovery and patient satisfaction. The Enhanced Recovery After Surgery (ERAS) program utilizes evidence-based multimodal interventions to reduce surgical stress and accelerate functional recovery. While day-surgery for AACLR has been proven feasible globally, its implementation in Vietnam remains limited due to systemic barriers. At the University Medical Center Ho Chi Minh City, although ERAS has been applied since 2022, the average length of stay for AACLR is 2.57 days, indicating significant room for optimization. This study aims to evaluate the current compliance with ERAS and the effectiveness of fully implementing these protocols to enable a day-surgery model. The research is designed in two phases, including a descriptive cohort and a clinical intervention. The intervention focuses on 06 core ERAS measures: * Comprehensive preoperative counseling and education. * Reducing preoperative fasting by using Maltodextrin 2 hours before surgery. * Standardized anesthesia combined with local infiltration analgesia (LIA). * Multimodal analgesia to minimize opioid consumption. * Early drainage removal within 6-8 hours postoperatively. * Immediate postoperative rehabilitation starting in the recovery unit. Effectiveness will be measured through various outcomes: the quality of early recovery via the QoR-15 score, mechanical knee function via the Lysholm Knee Scoring Scale (LKSS), and health-related quality of life via the EQ-5D-5L. Furthermore, a cost-effectiveness analysis (CEA) will be conducted using the Incremental Cost-Effectiveness Ratio (ICER). The study expects to demonstrate that strict ERAS adherence makes day-surgery AACLR feasible, reduces hospital-acquired infections, optimizes operating room productivity, and lessens the financial burden on both patients and the healthcare system.

Вмешательства

• Процедура Enhanced Recovery After Surgery
  Comprehensive preoperative counseling and education. Reducing preoperative fasting by using Maltodextrin 2 hours before surgery. Standardized anesthesia combined with local infiltration analgesia (LIA). Multimodal analgesia to minimize opioid consumption. Early drainage removal within 6-8 hours postoperatively. Immediate postoperative rehabilitation starting in the recovery unit.

Первичные конечные точки

• The quality of early recovery [Срок оценки: Preoperatively, 24 hours postoperatively]
• The mechanical knee function [Срок оценки: Preoperatively, 3 month, and 6 months postoperatively]
• Economic Evaluation [Срок оценки: 1 month, 3 months, 6 months postoperatively]

Критерии участия

Критерии включения

• Diagnosis of anterior cruciate ligament (ACL) rupture with indication for primary arthroscopic reconstruction
• Voluntary agreement to participate in the study and signing of the informed consent form

Критерии исключения

• Patients with concomitant knee pathologies requiring additional surgical procedures in the same session
• Presence of contraindications for ambulatory (day) surgery
• Failure to adhere to the scheduled follow-up visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07602231 · 60/GCN-HĐĐĐ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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