Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05761080
PHASE4

Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

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

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

772

Start Date

2021-04-22

Completion Date

2027-12

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

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

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