RECRUITING Phase 4 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT05761080

Registry updated: 2026-09-08

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Description

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).

Interventions

Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) (Drug)
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 (Drug)
Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days

Eligibility criteria

Inclusion criteria: * Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent. Exclusion criteria: * Patients requiring admission to the ICU with vasoactive support. Catarrhal or phlegmonous appendicitis. History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy. Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.

Conditions

Laparoscopic Appendectomy Complicated Appendicitis Periappendicular Abscess

Locations

Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain
Hospital Universitario Reina Sofía de Córdoba — Córdoba, Córdoba, Spain
Hospital Arnau de Villanova de Lleida — Lleida, Lleida, Spain
Hoapital Clínico San Carlos — Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocío — Seville, Sevilla, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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