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Acute AppendicitisAPENERASNCT07401407

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

An observational study of Acute Appendicitis and Appendectomy, run by Hospital Galdakao-Usansolo at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
199 participants
Where
4 sitesSpain
Study dates
7 Dec 2022to 26 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Galdakao-Usansolo

    Galdakao, Vizcaya, 48960

  • Hospital Universitari d'Igualada

    Igualada, Barcelona, 08700

  • Hospital Universitari Parc Taulí

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Keywords
ERAS, Enhanced Recovery After Surgery, RICA, urgent surgery, uncomplicated appendicitis, laparoscopic appendectomy, clinical pathway, adherence, early discharge, 30-day outcomes, patient satisfaction, Recuperación intensificada en Cirugía del Adulto
Medical subject headings
Appendicitis, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07401407
Study groupRoleWhat they receive
Urgent Uncomplicated Appendectomy CohortAdults 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall adherence to the RICA (ERAS Zaragoza 2022) pathway

    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.

    Measured: From day of surgery through postoperative day 1 or hospital discharge (whichever occurs first).

Secondary outcomes (8)

  1. Early discharge feasibility at 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.

    Measured: 8, 12 and 24 hours after surgery.

  2. Postoperative complications and severity (Clavien-Dindo)

    Postoperative complications will be recorded and graded according to the Clavien-Dindo classification.

    Measured: Up to 30 days after surgery.

  3. Length of hospital stay

    Length of stay will be measured as time from surgery to hospital discharge (reported in days and/or hours as available).

    Measured: From surgery to hospital discharge, assessed up to 30 days after surgery.

  4. Readmission within 30 days

    Unplanned readmissions for any cause will be recorded.

    Measured: Up to 30 days after surgery.

  5. Patient satisfaction score

    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. Higher scores indicate greater patient satisfaction.

    Measured: Up to 30 days after surgery.

  6. Saint-Antoine Score for early discharge eligibility prediction within 24 hours after 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).

    Measured: Baseline (preoperative; assessed immediately before surgery).

  7. Reintervention within 30 days

    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.

    Measured: Up to 30 days after surgery.

  8. All-cause mortality within 30 days

    All-cause mortality will be recorded.

    Measured: Up to 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start7 Dec 2022
  3. Primary completion27 Jan 2025
  4. Study completion26 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07401407
Sponsor's protocol ID
PI2022120
Acronym
APENERAS
Status last verified
Nov 2026
First submitted
14 Jan 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Postigo-Morales S, Ugarte-Sierra B, San-Juan-Gonzalez M, Ramirez-Rodriguez JM. [Implementation of the ERAS pathway in emergency surgery: adherence, barriers and facilitators]. J Healthc Qual Res. 2026 Jan-Feb;41(1):101170. doi: 10.1016/j.jhqr.2025.101170. Epub 2025 Oct 31. Spanish.

    PubMed 41175821

  • Scott MJ, Aggarwal G, Aitken RJ, Anderson ID, Balfour A, Foss NB, Cooper Z, Dhesi JK, French WB, Grant MC, Hammarqvist F, Hare SP, Havens JM, Holena DN, Hubner M, Johnston C, Kim JS, Lees NP, Ljungqvist O, Lobo DN, Mohseni S, Ordonez CA, Quiney N, Sharoky C, Urman RD, Wick E, Wu CL, Young-Fadok T, Peden CJ. Consensus Guidelines for Perioperative Care for Emergency Laparotomy Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations Part 2-Emergency Laparotomy: Intra- and Postoperative Care. World J Surg. 2023 Aug;47(8):1850-1880. doi: 10.1007/s00268-023-07020-6. Epub 2023 Jun 5.

    PubMed 37277507

  • Raimbert P, Voron T, Laroche S, O'Connell L, Debove C, Challine A, Parc Y, Lefevre JH. Ambulatory appendectomy for acute appendicitis: Can we treat all the patients? A prospective study of 451 consecutive ambulatory appendectomies out of nearly 2,000 procedures. Surgery. 2023 May;173(5):1129-1136. doi: 10.1016/j.surg.2023.01.003. Epub 2023 Feb 10.

    PubMed 36775758

  • Gignoux B, Blanchet MC, Lanz T, Vulliez A, Saffarini M, Bothorel H, Robert M, Frering V. Should ambulatory appendectomy become the standard treatment for acute appendicitis? World J Emerg Surg. 2018 Jun 28;13:28. doi: 10.1186/s13017-018-0191-4. eCollection 2018.

    PubMed 29988464

  • Ruiz-Tovar J, Llavero C, Perez-Lopez M, Garcia-Marin A. Implementation of an Enhanced Recovery After Surgery (ERAS) protocol for acute complicated and uncomplicated appendicitis. Tech Coloproctol. 2021 Sep;25(9):1073-1078. doi: 10.1007/s10151-021-02484-x. Epub 2021 Jun 26.

    PubMed 34173925

  • Trejo-Avila ME, Romero-Loera S, Cardenas-Lailson E, Blas-Franco M, Delano-Alonso R, Valenzuela-Salazar C, Moreno-Portillo M. Enhanced recovery after surgery protocol allows ambulatory laparoscopic appendectomy in uncomplicated acute appendicitis: a prospective, randomized trial. Surg Endosc. 2019 Feb;33(2):429-436. doi: 10.1007/s00464-018-6315-9. Epub 2018 Jul 9.

    PubMed 29987566

  • Di Saverio S, Podda M, De Simone B, Ceresoli M, Augustin G, Gori A, Boermeester M, Sartelli M, Coccolini F, Tarasconi A, De' Angelis N, Weber DG, Tolonen M, Birindelli A, Biffl W, Moore EE, Kelly M, Soreide K, Kashuk J, Ten Broek R, Gomes CA, Sugrue M, Davies RJ, Damaskos D, Leppaniemi A, Kirkpatrick A, Peitzman AB, Fraga GP, Maier RV, Coimbra R, Chiarugi M, Sganga G, Pisanu A, De' Angelis GL, Tan E, Van Goor H, Pata F, Di Carlo I, Chiara O, Litvin A, Campanile FC, Sakakushev B, Tomadze G, Demetrashvili Z, Latifi R, Abu-Zidan F, Romeo O, Segovia-Lohse H, Baiocchi G, Costa D, Rizoli S, Balogh ZJ, Bendinelli C, Scalea T, Ivatury R, Velmahos G, Andersson R, Kluger Y, Ansaloni L, Catena F. Diagnosis and treatment of acute appendicitis: 2020 update of the WSES Jerusalem guidelines. World J Emerg Surg. 2020 Apr 15;15(1):27. doi: 10.1186/s13017-020-00306-3.

    PubMed 32295644

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Appendicitis and Appendectomy, run by Hospital Galdakao-Usansolo at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall adherence to the RICA (ERAS Zaragoza 2022) pathway (time frame: From day of surgery through postoperative day 1 or hospital discharge (whichever occurs first).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07401407, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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