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NCT05761080
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Conditions: Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess
Sex: All
Ages: 2 Years – 17 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 772
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Location: Hospital de la Santa Creu i Sant Pau Barcelona Barcelona
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).
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.
Source: ClinicalTrials.gov (NCT05761080). StuddyBuddy aggregates publicly available trial information.