RICA (ERAS) Pathway Adherence and Early Discharge Feasibility After Urgent Uncomplicated Appendectomy (APENERAS) (APENERAS)

February 6, 2026 updated by: Susana Postigo Morales, Hospital Galdakao-Usansolo

APENERAS: A Prospective Multicenter Observational Study of RICA (ERAS) Pathway Adherence, Safety Outcomes, and Early Discharge Feasibility in Adults Undergoing Urgent Uncomplicated Appendectomy

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • Igualada, Barcelona, Spain, 08700
        • Hospital Universitari d'Igualada
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18-75 years undergoing urgent laparoscopic appendectomy for uncomplicated acute appendicitis in participating hospitals. The study evaluates adherence to the RICA (ERAS Zaragoza 2022) pathway in routine clinical practice, early discharge feasibility (8, 12, and 24 hours after surgery), and safety outcomes (complications, readmissions, reinterventions, and mortality) up to 30 days after surgery. No experimental intervention is introduced.

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall adherence to the RICA (ERAS Zaragoza 2022) pathway
Time Frame: 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.
From day of surgery through postoperative day 2 or hospital discharge (whichever occurs first).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early discharge feasibility at 8, 12 and 24 hours after surgery
Time Frame: 8, 12 and 24 hours after surgery.
Feasibility of early discharge will be assessed by intention-to-treat using a standardized discharge-readiness checklist (clinical stability, respiratory stability, orientation, mobility, oral intake, urination, wound status, and social support/logistics). The proportion of patients meeting all criteria at each timepoint (8h, 12h, 24h) will be reported.
8, 12 and 24 hours after surgery.
Postoperative complications and severity (Clavien-Dindo)
Time Frame: Up to 30 days after surgery.
Postoperative complications will be recorded and graded according to the Clavien-Dindo classification.
Up to 30 days after surgery.
Length of hospital stay
Time Frame: Time from surgery (Day 0) to hospital discharge (index hospitalization); assessed at discharge (followed until discharge, up to 30 days post-surgery).
Length of stay will be measured as time from surgery to hospital discharge (reported in days and/or hours as available).
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
Time Frame: Up to 30 days after discharge.
Unplanned readmissions for any cause will be recorded.
Up to 30 days after discharge.
Patient satisfaction score
Time Frame: Up to 30 days after surgery.
Patient satisfaction will be assessed using a structured survey delivered at hospital discharge and collected during postoperative follow-up. The overall satisfaction score (0-10 scale) and relevant domains will be analyzed.
Up to 30 days after surgery.
Saint-Antoine Score for early discharge eligibility prediction within 24 hours after surgery
Time Frame: Baseline (preoperative; assessed immediately before surgery).
The Saint-Antoine Score is a 5-point preoperative clinical score (range: 0 to 5) calculated at baseline (immediately before surgery) as the sum of five low-risk criteria (each criterion = 1 point; total score 0-5). Higher scores indicate a greater likelihood of eligibility for unplanned early discharge within 24 hours (better discharge readiness/lower-risk profile). Lower scores indicate a lower likelihood of early discharge eligibility. Predictive performance will be described (e.g., proportion eligible across score categories and discrimination metrics, as applicable).
Baseline (preoperative; assessed immediately before surgery).
Reintervention within 30 days
Time Frame: Up to 30 days after surgery.
Any unplanned reintervention after the index appendectomy, including surgical reoperation (e.g., re-laparoscopy/laparotomy) and other invasive procedures (e.g., percutaneous drainage), will be recorded.
Up to 30 days after surgery.
All-cause mortality within 30 days
Time Frame: Up to 30 days after surgery.
All-cause mortality will be recorded.
Up to 30 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Galdakao-Usansolo

Collaborators

Grupo Español de Rehabilitación Multimodal

Investigators

  • Study Director: Bakarne Ugarte-Sierra, PhD, Grupo español de rehabilitación multimodal (GERM)
  • Study Director: José Manuel Ramírez-Rodríguez, PhD, Grupo español de rehabilitación multimodal (GERM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

January 27, 2025

Study Completion (Actual)

February 26, 2025

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2022120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in publications will be shared. The shared dataset will contain coded study IDs and will exclude direct identifiers (e.g., name, medical record number, address). Variables will be minimized/modified as needed to reduce re-identification risk in accordance with GDPR and institutional policies.

IPD Sharing Time Frame

Available beginning 12 months after publication of the primary results and for 5 years thereafter.

IPD Sharing Access Criteria

Access will be granted to researchers with a clear research question and an appropriate analysis plan, subject to review and approval by the study team and compliance with GDPR and applicable institutional policies. Data will be provided in de-identified form after completion of a data sharing agreement. Requests should be submitted by email to: estudioapeneras@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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