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Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

Study acronym: FTAA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Nov 2027 → Jun 2028
See other at-risk trials from Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Nov 2027 to Jun 2028
    • Trial sites expanded: 7 → 12 locations
    • Study completion pushed from Dec 2027 to Jul 2028
    • Eligibility criteria expanded, about 5 words
    v8
  2. Study sites: 7 to 12v7
  3. Site details revised at 1 of 7 sitesv6
  4. Enrollment target: 158 to 772v5 Show 6 more changesShow less
    • Primary endpoint revised
    • Interventions: Amoxicillin clavulanic acid IV 3 days and PO until day 5 (Drug), Amoxicillin clavulanic acid IV during hospitalization (Drug) to Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center (Drug), Oral…
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 5 to 9
    • Study description shortened, about 40 words
    • Site details revised at 1 of 7 sites
  5. Study sites: 1 to 7v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Sep 2026 to Nov 2027
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised
    v3
  2. Phase: Not specified to Phase 4
    • Interventions: Amoxicillin clavulanic acid IV 3 days and PO until day 5 (Drug), Amoxicillin clavulanic acid IV during hospitalization (Drug)
    • Study description shortened, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05761080
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions
(from sponsor)		 Laparoscopic Appendectomy, Complicated Appendicitis, Periappendicular Abscess
Enrollment 772 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov