NCT05761080

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 772 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Complicated appendicitis is defined as the finding in the intraoperative study of a perforated, gangrenous or contaminated appendix with the presence of periappendicular abscess. Currently, the therapeutic approach for complicated appendicitis is based on monotherapy antibiotic management (except for drug allergies, appendicular peritonitis, immunosuppression or nosocomial acquisition) in the postoperative period, with a minimum duration of 5 days (intravenous treatment). Therefore, the minimum hospital stay in these patients is expected to be equal to or more than 5 days. Acute appendicitis represents the most frequent cause of acute abdomen in pediatric patients older than two years. It affects approximately 80,000 children in the European Union, making appendectomy one of the most frequent non-elective pediatric interventions performed by pediatric surgeons. In recent years, several ambispective studies have been carried out at national level applying new therapeutic models that allow shortening the hospital stay by applying more lax discharge criteria and reducing the duration of intravenous antibiotic treatment, without significant alterations in the rate of postoperative complications. By reducing hospital stay, the fast-track model not only brings clinical benefits to patients, but also economic benefits to the healthcare system.

Conditions

• Laparoscopic Appendectomy
• Complicated Appendicitis
• Periappendicular Abscess

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2021-04-22
• Primary completion: 2027-11-01
• Completion: 2027-12-01
• First posted: 2023-03-09
• Last updated: 2026-03-20

Locations

7 sites across 1 country: Spain