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| Name | Class |
|---|---|
| Grupo Español de Rehabilitación Multimodal | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bakarne Ugarte-Sierra, PhD | Grupo español de rehabilitación multimodal (GERM) | Study Director |
| JosĂ© Manuel RamĂrez-RodrĂguez, PhD | Grupo español de rehabilitaciĂłn multimodal (GERM) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain | ||
| Hospital Universitari d'Igualada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41175821 | Background | 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. | |
| 37277507 | Background | 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. |
| Label | URL |
|---|---|
| GERM - Protocolos Zaragoza (RICA/ERAS) - Urgencias: Uncomplicated Acute Appendicitis | View source |
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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.
Available beginning 12 months after publication of the primary results and for 5 years thereafter.
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
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| 8, 12 and 24 hours after surgery. |
| Postoperative complications and severity (Clavien-Dindo) | Postoperative complications will be recorded and graded according to the Clavien-Dindo classification. | Up to 30 days after surgery. |
| 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). | 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 | Unplanned readmissions for any cause will be recorded. | Up to 30 days after discharge. |
| 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. | Up to 30 days after surgery. |
| 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). | Baseline (preoperative; assessed immediately before surgery). |
| 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. | Up to 30 days after surgery. |
| All-cause mortality within 30 days | All-cause mortality will be recorded. | Up to 30 days after surgery. |
| Igualada |
| Barcelona |
| 08700 |
| Spain |
| Hospital Universitari Parc TaulĂ | Sabadell | Barcelona | 08208 | Spain |
| Hospital Galdakao-Usansolo | Galdakao | Vizcaya | 48960 | Spain |
| 36775758 | Background | 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. |
| 29988464 | Background | 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. |
| 34173925 | Background | 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. |
| 29987566 | Background | 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. |
| 32295644 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |