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

NCT07602231 | Not Yet Recruiting

• 1 other identifier: 60/GCN-HĐĐĐ
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture; Enhanced Recovery After Surgery (ERAS) Protocol; Ambulatory Surgery

Outcome Measures

Primary Outcomes (3)

• The quality of early recovery

  The quality of early recovery via the QoR-15 score

  Preoperatively, 24 hours postoperatively

• The mechanical knee function

  The mechanical knee function via the Lysholm Knee Scoring Scale

  Preoperatively, 3 month, and 6 months postoperatively

• Economic Evaluation

  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

Study Arms (2)

Baseline

NO INTERVENTION

The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)

Enhanced Recovery After Surgery

EXPERIMENTAL

The patient cohort receiving the full implementation of 06 core Enhanced Recovery After Surgery (ERAS) measures, corresponding to the interventional phase of the study

Procedure: Enhanced Recovery After Surgery

Interventions

Enhanced Recovery After Surgery PROCEDURE

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.

Enhanced Recovery After Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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
• Access Criteria: 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.