Appendectomy Versus Conservative Treatment for Uncomplicated Acute Appendicitis
NCT03080103
Acute Appendicitis, Antibiotic Therapy
Muravera, Cagliari, Italy
View Trial DetailsNCT Number: NCT07401407
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.
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Notify Me18 year–75 year
All sexes
Observational
Hospital General Universitario de Elche, Elche, Alicante, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to 30 days after surgery.
Postoperative complications will be recorded and graded according to the Clavien-Dindo classification.
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 frame: Up to 30 days after discharge.
Unplanned readmissions for any cause will be recorded.
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.
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).
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.
Time frame: Up to 30 days after surgery.
All-cause mortality will be recorded.
Hospital Galdakao-Usansolo
Other Gov
APENERAS: A Prospective Multicenter Observational Study of RICA (ERAS) Pathway Adherence, Safety Outcomes, and Early Discharge Feasibility in Adults Undergoing Urgent Uncomplicated Appendectomy
Acronym: APENERAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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