APENERAS: A Prospective Multicenter Observational Study of RICA (ERAS) Pathway Adherence, Safety Outcomes, and Early Discharge Feasibility in Adults Undergoing Urgent Uncomplicated Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 4
- 主要终点
- Overall adherence to the RICA (ERAS Zaragoza 2022) pathway
研究概览
简要总结
This multicenter, prospective observational study (APENERAS) evaluates adherence to the RICA (ERAS Zaragoza 2022) perioperative care pathway in adults undergoing urgent laparoscopic appendectomy for uncomplicated acute appendicitis. The study aims to describe real-world adherence to the pathway across participating hospitals and to explore its association with patient safety and recovery outcomes.
Key outcomes include postoperative complications (including severity), length of hospital stay, and readmissions within 30 days. Patient-reported satisfaction is also assessed using a structured survey. In addition, the study evaluates the feasibility of early discharge/ambulatory management by intention-to-treat, using a standardized checklist of clinical, functional, and social discharge criteria assessed during the first 24 hours after surgery.
No changes to usual clinical care are introduced. Data are collected from routine perioperative management and follow-up.
详细描述
APENERAS is a prospective, multicenter observational study conducted in adult patients undergoing urgent laparoscopic appendectomy for uncomplicated acute appendicitis. The study assesses real-world adherence to the RICA (ERAS Zaragoza 2022) pathway, a structured set of perioperative recommendations intended to optimize recovery and standardize care in urgent surgery settings.
The primary objective is to quantify overall adherence and adherence by individual components of the pathway. Secondary objectives include evaluating the association between adherence and (1) postoperative safety outcomes (complications and severity classification), (2) efficiency outcomes (length of stay), (3) unplanned healthcare use (readmissions within 30 days), and (4) patient experience (satisfaction survey completed at discharge). In addition, feasibility of early discharge/ambulatory management is assessed by intention-to-treat using a standardized discharge-readiness checklist (clinical stability, pain control with oral analgesia, oral tolerance, mobilization, spontaneous urination, wound status, and social support), evaluated during the first postoperative day.
Candidate profiles for early discharge are also explored using established clinical prediction tools (e.g., Saint-Antoine Score), together with demographic and clinical covariates. Follow-up is performed up to 30 days after surgery to capture postoperative events and readmissions.
This study does not involve any experimental intervention, drug, or device, and does not require changes to standard clinical practice. It is based on systematic data collection from routine care processes and clinical records in each participating center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years.
- •Immunocompetent patients.
- •ASA physical status I-III.
- •Preoperative diagnosis of uncomplicated acute appendicitis (based on clinical assessment, laboratory tests, and imaging such as ultrasound and/or CT according to availability).
- •Indication for urgent appendectomy for uncomplicated appendicitis.
- •Laparoscopic approach.
- •Expected operative time < 90 minutes.
- •Cooperative patient able to understand and follow instructions.
- •Voluntary participation and written informed consent.
- •Adequate social/family support (availability of a responsible adult for transport home and support during the first postoperative days).
- •Travel time from home to hospital < 1 hour and access to transportation.
- •Acceptable home environment for recovery (telephone access and basic habitability/hygiene).
排除标准
- •ASA physical status IV.
- •Age < 18 years or > 75 years.
- •BMI > 35 kg/m² with significant respiratory or cardiovascular complications.
- •Ischemic heart disease class IV or acute myocardial infarction within the last 6 months.
- •Congestive heart failure NYHA class III-IV.
- •Sleep apnea or severe COPD, or need for home oxygen therapy.
- •Poorly controlled diabetes mellitus.
- •Severe psychiatric disorders, drug addiction, or severe alcoholism.
- •History of major anesthesia-related complications or malignant hyperthermia.
- •Epilepsy.
- •Pregnancy.
- •Use of anticoagulants, MAO inhibitors, systemic corticosteroids, or immunosuppressive drugs.
- •Complicated appendicitis (gangrenous or perforated appendicitis, abscess, diffuse peritonitis).
- •Severe sepsis.
- •Primary open appendectomy or conversion to open surgery.
- •Positive SARS-CoV-2 PCR or symptoms compatible with COVID-19.
研究组 & 干预措施
Urgent Uncomplicated Appendectomy Cohort
Adults undergoing urgent laparoscopic appendectomy for uncomplicated acute appendicitis in participating hospitals. Perioperative management follows routine clinical practice. The adherence to the RICA (ERAS) pathway items is assessed, along with safety outcomes and early discharge feasibility.
结局指标
主要结局
Overall adherence to the RICA (ERAS Zaragoza 2022) pathway
时间窗: From day of surgery through postoperative day 2 or hospital discharge (whichever occurs first).
Overall adherence will be quantified as the proportion (%) of prespecified RICA (ERAS Zaragoza 2022) items fulfilled per participant and overall, using the study case report form. Adherence will be reported as a global percentage and by individual pathway components.
次要结局
- Early discharge feasibility at 8, 12 and 24 hours after surgery(8, 12 and 24 hours after surgery.)
- Postoperative complications and severity (Clavien-Dindo)(Up to 30 days after surgery.)
- Length of hospital stay(Time from surgery (Day 0) to hospital discharge (index hospitalization); assessed at discharge (followed until discharge, up to 30 days post-surgery).)
- Readmission within 30 days(Up to 30 days after discharge.)
- Patient satisfaction score(Up to 30 days after surgery.)
- Saint-Antoine Score for early discharge eligibility prediction within 24 hours after surgery(Baseline (preoperative; assessed immediately before surgery).)
- Reintervention within 30 days(Up to 30 days after surgery.)
- All-cause mortality within 30 days(Up to 30 days after surgery.)
研究者
Susana Postigo Morales
Staff Anesthesiologist
Hospital Galdakao-Usansolo