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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

RecruitingNA

Sponsor: Ahmet Burak Doğan, MD

Conditions: Appendectomy, Laparoscopic, Acute Appendicitis, Pediatric Surgery, ERAS

Interventions: Comprehensive 20-Item Pediatric ERAS Protocol

Countries: Turkey (Türkiye)

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 overview

Sex: ALL

Age: 5 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (1)

Kayseri, Kayseri, Turkey (Türkiye)