Health Trials

About this trial

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

Qualifiers

Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

772 Participants
are divided into 2 treatment groups

Locations

7
Hospital de la Santa Creu i Sant Pau BarcelonaBarcelona, Spain
Hospital Germans Trias i Pujol Badalona Spain
Hospital del Mar Barcelona Spain
Hospital Sant Joan de Deu Esplugues de Llobregat Spain

Sponsors and collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Lead sponsor

Source ClinicalTrials.gov