Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Condition(s) studied

Investigational drug(s) / intervention(s)

Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day): Inpatient postoperative intravenous treatment according to the established protocol in each center for 3 days, followed of oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) for two more days at home

Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center: Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days

Study 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

Primary outcome measure(s)

• Adverse events — 30 days
  The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.

Trial sites (12)

More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain