Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Recruiting now · Phase 4
Conditions studied: Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess
In brief
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).
Key facts
- Study ID
- NCT05761080
- Run by
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- People needed
- 772
- Starts
- 2021-04-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-20
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
You may not qualify if…
- Peritonitis with sepsis criteria. 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.
Where it is running
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (enrolling)
- Hospital Germans Trias i Pujol — Badalona, Spain (enrolling)
- Hospital del Mar — Barcelona, Spain (enrolling)
- Hospital Sant Joan de Deu — Esplugues de Llobregat, Spain (enrolling)
- Hospital Universitario Dr. Josep Trueta — Girona, Spain (enrolling)
- Complejo Universitario Hospitalario de Santiago de Compostela — Santiago de Compostela, Spain (enrolling)
- Hospital Joan XXIII — Tarragona, Spain (enrolling)
Full record on ClinicalTrials.gov
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