Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols for Arthroscopic Anterior Cruciate Ligament Reconstruction in an Ambulatory Surgery Setting
22 mai 2026 mis à jour par: University Medical Center Ho Chi Minh City (UMC)
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
115
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: Conventional care
The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Economic Evaluation
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
18 mai 2026
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
15 mai 2026
Première soumission répondant aux critères de contrôle qualité
15 mai 2026
Première publication (Réel)
22 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 60/GCN-HĐĐĐ
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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...).
Délai de partage IPD
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
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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