Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Clinical Outcomes and Institutional Integration of the ERAS (Enhanced Recovery After Surgery) Protocol in Pediatric Appendicetomies: A Mixed Methodological IDEAL (Idea, Development, Exploration, Assessment, Long-term Study) 2a Preliminary Study
Ahmet Burak Doğan, MD
100 participants
Jun 16, 2026
INTERVENTIONAL
Conditions
Summary
Acute appendicitis is the most common surgical emergency in children. Despite the widespread adoption of laparoscopic appendectomy, postoperative care still varies widely between institutions, with prolonged fasting, opioid-based analgesia, delayed feeding, and routine drain placement being common. Enhanced Recovery After Surgery (ERAS) is an evidence-based, multidisciplinary care pathway that has been shown in adults - and increasingly in children - to reduce length of stay, opioid consumption, and postoperative complications. This single-center, prospective, single-arm cohort feasibility study (IDEAL Stage 2a) tests whether a comprehensive 20-item pediatric ERAS protocol, adapted for minimally invasive appendectomy in children aged 5-18 with non-complicated acute appendicitis (ASA I-II), can be implemented with high fidelity and acceptable safety in a tertiary academic pediatric surgery department. We aim to enroll 100 patients to obtain \~80 evaluable cases. The primary endpoint is the global ERAS compliance rate (target ≥80%, with the lower bound of the 95% confidence interval staying above 70%). Co-primary safety endpoints include Clavien-Dindo ≥III complications and 30-day unplanned readmission rates, both targeted at \<5%. Secondary endpoints include time to medical readiness for discharge, actual length of stay, opioid sparing, and parent-reported outcomes. The study includes a structured run-in phase (first 5 patients) with explicit decision logic to either continue with the protocol unchanged or revise it before full enrollment. Audit-and-feedback cycles every 20 patients monitor compliance drift. The findings will inform a definitive institutional clinical guideline and provide hypothesis-generating data for future multi-center trials.
Eligibility
Inclusion Criteria5
- Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent).
- Acute appendicitis without preoperative radiologic or clinical evidence of complication/perforation, who are candidates for and accept laparoscopic surgery.
- ASA Physical Status I (healthy) or ASA II (mild systemic disease).
- Family/legal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials.
- Written informed consent from parents/legal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent.
Exclusion Criteria5
- Preoperative imaging or clinical evidence of complicated appendicitis (perforation, generalized peritonitis, intra-abdominal abscess) anticipated to require an extended procedure (anastomosis, resection, or extensive peritoneal irrigation).
- History of chronic pain syndrome or regular/sustained opioid use within the past 3 months.
- Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis).
- ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery/mobilization.
- Anatomic/mechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).
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Interventions
A multidisciplinary 20-item perioperative care pathway spanning preoperative (5 items: family education, fasting management with clear fluids permitted up to 2 hours preoperatively, no oral carbohydrate loading, no mechanical bowel preparation, restricted sedative premedication), intraoperative (9 items: timely prophylactic antibiotics within 30-60 min of incision, regional analgesia with 0.25% bupivacaine port-site infiltration, short-acting anesthetic agents, restricted intraoperative opioid \<0.1 mg/kg morphine equivalent, active normothermia \>36 °C, goal-directed euvolemic fluid therapy 3-7 mL/kg/h, minimally invasive surgical approach, avoidance of routine drains/tubes, universal PONV prophylaxis with ondansetron + dexamethasone 0.15 mg/kg max 8 mg), and postoperative (6 items: early NG tube removal, early oral feeding within 2-4 hours, early IV fluid discontinuation, early mobilization with corridor walk by hour 6, multimodal scheduled zigzag oral analgesia with paracetamol 15 mg/
Locations(1)
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NCT07643285