RecruitingPhase 4NCT05761080

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


Sponsor

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

Enrollment

772 participants

Start Date

Apr 22, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center and a drug called Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day) for people with complicated appendicitis, laparoscopic appendectomy, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOral 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

DRUGInpatient 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


Locations(7)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Spain

Hospital Universitario Dr. Josep Trueta

Girona, Spain

Complejo Universitario Hospitalario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Joan XXIII

Tarragona, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05761080


Related Trials