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Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Summary
To evaluate whether a postoperative therapeutic strategy, Fast Track, aimed at shortening hospital stay in pediatric patients undergoing laparoscopic appendectomy for complicated acute appendicitis, yields outcomes that are not inferior to the standard therapeutic model in terms of the combined variable of adverse events within 30 days postoperatively (including postoperative abdominal abscess, peritonitis, surgical wound complications, reintervention, sepsis, or death).
Official title: Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
772
Start Date
2021-04-22
Completion Date
2027-12
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)
Inpatient postoperative intravenous treatment according to the established protocol in each center for 3 days, followed of oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) for two more days at home
Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center
Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days
Locations (7)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Spain
Hospital Universitario Dr. Josep Trueta
Girona, Spain
Complejo Universitario Hospitalario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Joan XXIII
Tarragona, Spain