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| Name | Class |
|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional care | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperatively, 24 hours postoperatively |
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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...).
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 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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2026 | May 13, 2026 |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
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