RICA (ERAS) Pathway Adherence and Early Discharge Feasibility After Urgent Uncomplicated Appendec… (NCT07401407) | Clinical Trial Compass
CompletedNot Applicable
RICA (ERAS) Pathway Adherence and Early Discharge Feasibility After Urgent Uncomplicated Appendectomy (APENERAS)
Spain193 participantsStarted 2022-12-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 immun…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall adherence to the RICA (ERAS Zaragoza 2022) pathway
Timeframe: From day of surgery through postoperative day 2 or hospital discharge (whichever occurs first).