Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

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.

Conditions

• Appendectomy, Laparoscopic
• Acute Appendicitis
• Pediatric Surgery
• ERAS

Interventions

OTHER

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).

Sponsors & Collaborators

• Ahmet Burak Doğan, MD

  lead OTHER

Principal Investigators

• Ahmet B DOĞAN, Associate Professor · Erciyes University, Faculty of Medicine, Department of Pediatric Surgery

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2027-04-30

Completion

2027-08-31

Countries

• Turkey (Türkiye)

Study Locations