Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial

What this Trial Is About

This research aims to evaluate whether a faster postoperative treatment approach called Fast Track can safely shorten hospital stays for children aged 2 to 17 who have complicated acute appendicitis and undergo laparoscopic appendectomy. Complicated appendicitis involves a perforated, gangrenous, or contaminated appendix with a periappendicular abscess. The study compares Fast Track to the standard care model by assessing if adverse events within 30 days after surgery are not worse with the faster approach. Two treatment plans are compared: the Fast Track group receives intravenous antibiotics in the hospital for 3 days followed by oral amoxicillin-clavulanic acid at home for 2 days, while the standard care group receives intravenous antibiotics for 5 days in the hospital. Both treatments follow protocols set by each participating center. This randomized, open-label trial evaluates whether the Fast Track model can reduce hospital stay length without increasing complications. Participants will be monitored for 30 days after surgery to track adverse events such as abdominal abscesses, infections, wound problems, reinterventions, sepsis, or death. Additional assessments include hospital readmissions, antibiotic side effects, quality of life measures on days 2, 5, 14, and 30, satisfaction questionnaires, lab markers like procalcitonin, antibiotic use, and associated costs. The study plans to provide detailed safety and outcome data while potentially benefiting patients and healthcare systems by reducing hospitalization time.

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics