NCT07401407

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

January 14, 2026

Last Update Submit

February 6, 2026

Conditions

Acute AppendicitisAppendectomyAmbulatory Surgery

Keywords

ERASEnhanced Recovery After SurgeryRICAurgent surgeryuncomplicated appendicitislaparoscopic appendectomyclinical pathwayadherenceearly discharge30-day outcomespatient satisfactionRecuperación intensificada en Cirugía del Adulto

Outcome Measures

Primary Outcomes (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.

    From day of surgery through postoperative day 2 or hospital discharge (whichever occurs first).

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital Universitari d'Igualada

Igualada, Barcelona, 08700, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Related Publications (7)

  • 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.

    PMID: 41175821BACKGROUND

  • 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.

    PMID: 37277507BACKGROUND

  • 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.

    PMID: 36775758BACKGROUND

  • 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.

    PMID: 29988464BACKGROUND

  • 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.

    PMID: 34173925BACKGROUND

  • 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.

    PMID: 29987566BACKGROUND

  • 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.

    PMID: 32295644BACKGROUND

Related Links

MeSH Terms

Conditions

AppendicitisPatient Satisfaction

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bakarne Ugarte-Sierra, PhD

    Grupo español de rehabilitación multimodal (GERM)

    STUDY DIRECTOR

  • José Manuel Ramírez-Rodríguez, PhD

    Grupo español de rehabilitación multimodal (GERM)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

January 14, 2026

First Posted

February 10, 2026

Study Start

December 7, 2022

Primary Completion

January 27, 2025

Study Completion

February 26, 2025

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Available beginning 12 months after publication of the primary results and for 5 years thereafter.
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

Locations

ES(4)