Condition: Appendectomy, Laparoscopic · Acute Appendicitis · Pediatric Surgery · Sponsor: Ahmet Burak Doğan, MD
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 continu…
This description comes directly from the study's public registry record.
Ahmet B DOĞAN, Associate Professor · +90 533 390 86 34 · drkarden@gmail.com
Yasin Sipahi, Research Assistant · +90 507 119 00 58 · sipahiysn@hotmail.com
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| Erciyes University Faculty of Medicine, Department of Pediatric Surgery | Kayseri, Kayseri, Turkey (Türkiye) | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07643285