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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Sponsor: Ahmet Burak Doğan, MD
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.
Official title: 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
Key Details
Gender
All
Age Range
5 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-06-15
Completion Date
2027-08
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Comprehensive 20-Item Pediatric ERAS Protocol
20-item multidisciplinary pathway. Preoperative (5): family education; clear fluids up to 2 h; no carbohydrate loading; no bowel preparation; restricted premedication. Intraoperative (9): prophylactic antibiotics within 120 min before incision (60 min until patient 41; agents given separately from patient 42); institutional IV paracetamol 15 mg/kg at induction; bupivacaine port-site infiltration; short-acting anesthetics; opioid \<0.1 mg/kg morphine equivalent; normothermia \>36 C; total IV fluid 3-7 mL/kg/h (incl. drug diluents); minimally invasive approach; no routine drains/tubes; PONV prophylaxis (ondansetron+dexamethasone). Postoperative (6): early NG tube removal; oral feeding within 2-4 h; early IV discontinuation; mobilization (corridor by hour 6); zigzag oral analgesia q3h to hour 21 (ibuprofen 10 mg/kg alternating with paracetamol 15 mg/kg; ibuprofen first from patient 41); criterion-based discharge; paracetamol-only discharge Rx (15 mg/kg/dose from patient 41).
Locations (1)
Erciyes University Faculty of Medicine, Department of Pediatric Surgery
Kayseri, Kayseri, Turkey (Türkiye)