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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Ho Chi Minh City (UMC)

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Recovery After Surgery

    Procedure/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.

Treatment groups

115 Participants
are divided into 2 treatment groups
Group A: Conventional careNo intervention 0 interventions
Group B: Enhanced Recovery After SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The quality of early recovery

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.

Time frame
Preoperatively, 24 hours postoperatively
2

The mechanical knee function

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.

Time frame
Preoperatively, 3 month, and 6 months postoperatively
3

Economic Evaluation

Economic evaluation of ERAS vs. conventional care using the EQ-5D-5L to calculate ICER per QALY gained

Time frame
1 month, 3 months, 6 months postoperatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Ho Chi Minh City (UMC)

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Collaborator

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