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Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

RecruitingPhase 4Ages 2 Years - 17 YearsAllFundació Institut de Recerca de l'Hospital de la …
NCT05761080 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

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

12 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Spain
Hospital Arnau de Villanova de Lleida
Lleida, Spain
Hoapital Clínico San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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