Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
Locations
Other Locations
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Sant Joan de Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitario Dr. Josep Trueta
RECRUITING
Girona
Complejo Universitario Hospitalario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Joan XXIII
RECRUITING
Tarragona
Contact Information
Primary
Maria Jose Martinez-Zapata, MD, PhD
mmartinezz@santpau.cat
+34935537901
Backup
Carlos Leganés Villanueva, MD
cleganes@santpau.cat
+34935537634
Time Frame
Start Date: 2021-04-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 772
Treatments
Experimental: Experimental branch
Inpatient postpoperative intravenous antibiotic 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
Active_comparator: Control branch
Inpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days
Related Therapeutic Areas
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau