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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Sponsor: Ahmet Burak Doğan, MD • ClinicalTrials.gov ID: NCT07643285

Registry updated: 2026-10-15

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Description

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.

Interventions

Comprehensive 20-Item Pediatric ERAS Protocol (Other)
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).

Eligibility criteria

Inclusion Criteria: 1. Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent). 2. Acute appendicitis without preoperative radiologic or clinical evidence of complication/perforation, who are candidates for and accept laparoscopic surgery. 3. ASA Physical Status I (healthy) or ASA II (mild systemic disease). 4. Family/legal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials. 5. Written informed consent from parents/legal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent. Exclusion Criteria: 1. 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). 2. History of chronic pain syndrome or regular/sustained opioid use within the past 3 months. 3. Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis). 4. ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery/mobilization. 5. Anatomic/mechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).

Conditions

Appendectomy, Laparoscopic Acute Appendicitis Pediatric Surgery ERAS

Locations

Erciyes University Faculty of Medicine, Department of Pediatric Surgery — Kayseri, Kayseri, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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