Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-17
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 groupsSponsors and collaborators
Source ClinicalTrials.gov