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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: Conventional care
The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Economic Evaluation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 60/GCN-HĐĐĐ
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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