New treatment approach for complicated appendicitis in children
Evaluation of a Therapeutic Strategy to Shorten Hospital Stay in Complicated Pediatric Appendicitis: A Randomized, Parallel, Multicenter, Open-Label Clinical Trial
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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 772 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 7 sites (Barcelona, Barcelona and 6 other locations) |
| Trial ID | NCT05761080 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 16 years diagnosed with complicated appendicitis who meet specific postoperative criteria.
Not a fit: Patients with chronic conditions requiring elective surgery or contraindications to the study medication may not benefit from this trial.
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 performed: Previous studies have indicated success with similar fast track approaches in pediatric appendicitis management.
Eligibility criteria
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: * 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.
Where this trial is running
Barcelona, Barcelona and 6 other locations
- 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)
- Hospital Joan XXIII — Tarragona, Spain (Recruiting)
Study contacts
- Study coordinator: Maria Jose Martinez-Zapata, MD, PhD
- Email: mmartinezz@santpau.cat
- Phone: +34935537901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.