Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics
FTAA
Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
2 other identifiers
interventional
772
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2021
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2021
CompletedFirst Submitted
Initial submission to the registry
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 20, 2026
March 1, 2026
6.5 years
February 27, 2023
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
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.
30 days
Secondary Outcomes (9)
Individualized incidence of adverse events
30 days
Hospital readmission rate
30 days
Adverse reactions related to antibiotic treatment
14 days
Need for percutaneous drainage
30 days
Quality of life measure
day 2, and at 5, 14, and 30 postoperative days
- +4 more secondary outcomes
Study Arms (2)
Experimental branch
EXPERIMENTALInpatient 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
Control branch
ACTIVE COMPARATORInpatient postoperative intravenous treatment according to the protocol established in each center, lasting 5 days
Interventions
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 for 5 days
Eligibility Criteria
You may qualify if:
- Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.
You may not qualify if:
- Peritonitis with sepsis criteria. Catarrhal or phlegmonous appendicitis. History of cystic fibrosis, Crohn's disease, or transplant that may interfere with the usual postoperative course of laparoscopic appendectomy.
- Contraindication to the administration of amoxicillin-clavulanic acid. Refusal to participate in the study by parents/legal guardians.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
17th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT). Eur J Clin Pharmacol. 2025;81(Suppl 1):1-63. doi:10.1007/s00228-025-03859-x. Poster 374.
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Maria Jose Martinez-Zapata, MD, PhD
Institut de Recerca Sant Pau
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Main research coordinator
Study Record Dates
First Submitted
February 27, 2023
First Posted
March 9, 2023
Study Start
April 22, 2021
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share