Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Comprehensive 20-Item Pediatric ERAS Protocol: A multidisciplinary 20-item perioperative pathway. Preoperative (5 items): family education; clear fluids up to 2 h preoperatively; no carbohydrate loading; no bowel preparation; restricted sedative premedication. Intraoperative (9 items): prophylactic antibiotics within 30-60 min of incision; 0.25% bupivacaine port-site infiltration; short-acting anesthetics; intraoperative opioid \<0.1 mg/kg morphine equivalent; active normothermia \>36 C; goal-directed fluid therapy 3-7 mL/kg/h; minimally invasive approach; no routine drains/tubes; PONV prophylaxis (ondansetron + dexamethasone). Postoperative (6 items): early NG tube removal; early oral feeding within 2-4 h; early IV fluid discontinuation; early mobilization (corridor walk by hour 6); scheduled multimodal zigzag oral analgesia (paracetamol 15 mg/kg alternating with ibuprofen 10 mg/kg, scheduled doses through postoperative hour 21); criterion-based discharge planning; paracetamol-only discharge prescription (from patient 21 onward).

Study 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

Primary outcome measure(s)

• Global ERAS Compliance Rate — Index hospitalization, from preoperative admission through actual discharge (typically ≤72 hours).
  Proportion of patients in the evaluable cohort (n≈80) achieving full compliance with at least 80% of the applicable 20 ERAS items (i.e., at least 16 of 20 items implemented as planned). Each of the 20 items is dichotomously coded (1 = achieved, 0 = not achieved). Up to 3 items may be voided per patient due to medical contraindication; patients with ≥4 voided items are classified as "complex" and excluded from the primary analysis. The compliance rate is reported as a point estimate with Wilson 95% confidence interval. The pre-specified success criterion is the lower bound of the 95% CI exceeding 70%.
• Postoperative Major Complication and Unplanned Readmission Rate (30-day)(Co-primary) — 30 days postoperative.
  Composite of (a) Clavien-Dindo Grade III or higher major complications occurring within 30 days of surgery, AND (b) unplanned true inpatient readmission within 30 days of discharge. Each component is reported separately as a proportion with 95% CI. The pre-specified success criterion is each component remaining below 5%. Both feasibility (Primary Outcome 1) and this safety composite must be met for the protocol to be considered feasible-and-safe.

Trial sites (1)

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