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

22 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

115

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Sin intervención: Conventional care
The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Economic Evaluation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

18 de mayo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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...).

Marco de tiempo para compartir 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

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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