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NCT07643285
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Conditions: Appendectomy, Laparoscopic, Acute Appendicitis, Pediatric Surgery, ERAS
Sex: All
Ages: 5 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Ahmet Burak Doğan, MD
Location: Erciyes University Faculty of Medicine, Department of Pediatric Surgery Kayseri Kayseri
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 \
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).
Source: ClinicalTrials.gov (NCT07643285). StuddyBuddy aggregates publicly available trial information.