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

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

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.

研究概览

研究类型

介入性

注册 (估计的)

115

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Enhanced Recovery After Surgery
The patient cohort receiving the full implementation of 06 core Enhanced Recovery After Surgery (ERAS) measures, corresponding to the interventional phase of the study
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.
无干预:Conventional care
The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Economic Evaluation
大体时间:1 month, 3 months, 6 months postoperatively
Economic evaluation of ERAS vs. conventional care using the EQ-5D-5L to calculate ICER per QALY gained
1 month, 3 months, 6 months postoperatively
The quality of early recovery
大体时间:Preoperatively, 24 hours postoperatively
The quality of early recovery via the Quality of Recovery-15 (QoR-15). QoR-15 scale is a patient-reported outcome questionnaire used to assess the quality of postoperative recovery. The scale consists of 15 items evaluating 5 dimensions: emotional state, physical comfort, psychological support, physical independence, and pain. Each item is scored from 0 to 10. The total score ranges from 0 to 150, where a score of 0 represents the worst possible recovery and a score of 150 represents the excellent/best possible recovery. Higher scores indicate a better postoperative recovery outcome.
Preoperatively, 24 hours postoperatively
The mechanical knee function
大体时间:Preoperatively, 3 month, and 6 months postoperatively
The mechanical knee function via the Lysholm Knee Scoring Scale (LKSS). LKSS is a clinician-administered, patient-reported instrument designed to evaluate knee function, specifically for ligament and meniscal injuries. It consists of 8 items: limp (5 points), support (5 points), locking (15 points), instability (25 points), pain (25 points), swelling (10 points), stair-climbing (10 points), and squatting (5 points). The total score ranges from 0 to 100, where a score of 0 represents the worst possible knee function/severe symptoms and a score of 100 represents a normal, asymptomatic knee. Higher scores indicate a better clinical and functional outcome.
Preoperatively, 3 month, and 6 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月18日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). This includes demographic characteristics, preoperative clinical status, intraoperative ERAS compliance metrics, and primary/secondary outcomes (VAS scores, postoperative complications, QoR-15, Lysholm scores, and EQ-5D-5L data...).

IPD 共享时间框架

Data will be available for sharing beginning 6 months and ending 3 years following the publication of the primary manuscript in a peer-reviewed journal

IPD 共享访问标准

Access will be granted to qualified researchers who provide a methodologically sound proposal. To gain access, requesters must submit a formal research proposal and a signed data use agreement. The proposal must be approved by an independent review committee. Data will be shared only for the purpose of achieving the aims outlined in the approved proposal.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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