Clinical trial Recruiting at 7 sites Phase 4 Interventional Ages 2 to 17

New treatment approach for complicated appendicitis in children

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

Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT05761080 · Data updated 2026-11-12

This study tests a new treatment plan for children with complicated appendicitis to see if it can help them recover faster and avoid complications after surgery.

Quick facts

PhasePhase 4
Study typeInterventional
Ages2 Years to 17 Years
SexAll
Enrollment772 (estimated)
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Academic / other
Locations12 sites (Barcelona, Barcelona and 11 other locations)
StatusRecruiting
StartedApril 22, 2021
Main results expectedJune 2028
Study endsJuly 2028
Registry record updatedSeptember 8, 2026
Trial IDNCT05761080 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 2 to 16 years diagnosed with complicated appendicitis who meet specific postoperative criteria.

Probably not a fit

Patients with chronic conditions requiring elective surgery or contraindications to the study medication may not benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a fast track therapeutic model for pediatric patients undergoing laparoscopic appendectomy for complicated appendicitis. The study focuses on reducing postoperative complications, specifically abdominal abscesses, by implementing a new protocol for antibiotic management and discharge criteria. Patients will receive intravenous amoxicillin-clavulanic acid during hospitalization, followed by oral treatment, aiming to shorten hospital stays without increasing complication rates. The trial is based on previous studies that have shown promising results in similar therapeutic approaches.

Why it matters

Potential benefit: If successful, this approach could significantly reduce hospital stays and improve recovery times for children with complicated appendicitis.

How similar studies have gone: Previous studies have indicated success with similar fast track approaches in pediatric appendicitis management.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

* Ages 2 to 17 years. Intraoperative diagnosis of complicated appendicitis. Laparoscopic appendectomy. Agreement to participate in the study with signed informed consent.

Exclusion criteria:

* Patients requiring admission to the ICU with vasoactive support. 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.

Where it's running

  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona, Spain
    Recruiting
  • Hospital Germans Trias i Pujol
    Badalona, Spain
    Recruiting
  • Hospital del Mar
    Barcelona, Spain
    Recruiting
  • Hospital Sant Joan de Deu
    Esplugues de Llobregat, Spain
    Recruiting
  • Hospital Universitario Dr. Josep Trueta
    Girona, Spain
    Recruiting
  • Complejo Universitario Hospitalario de Santiago de Compostela
    Santiago de Compostela, Spain
    Recruiting
Show 6 more locations
  • Hospital Joan XXIII
    Tarragona, Spain
    Recruiting
  • Hospital Universitario Reina Sofía de Córdoba
    Córdoba, Córdoba, Spain
    Not yet recruiting
  • Hospital Arnau de Villanova de Lleida
    Lleida, Lleida, Spain
    Not yet recruiting
  • Hoapital Clínico San Carlos
    Madrid, Madrid, Spain
    Not yet recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Spain
    Active not recruiting
  • Hospital Universitario Virgen del Rocío
    Seville, Sevilla, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.