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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：Conventional care
The patient cohort managed under the conventional care protocol (corresponding to the descriptive cohort phase)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Economic Evaluation
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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