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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 772 (estimated) |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 12 sites (Barcelona, Barcelona and 11 other locations) |
| Status | Recruiting |
| Started | April 22, 2021 |
| Main results expected | June 2028 |
| Study ends | July 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05761080 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
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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
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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
- Study coordinator: Maria Jose Martinez-Zapata, MD, PhD
- Email: mmartinezz@santpau.cat
- Phone: +34935537901
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pre-incisional ropivacaine plus Diprospan for pain after laparoscopic surgery
This study tests whether injecting ropivacaine with Diprospan before surgery reduces pain after laparoscopic gallbladder, appendix, or hernia operations compared with ropivacaine alone.
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Oral Lactulose to Help GI Recovery After Complicated Appendicitis
This trial tests whether giving lactulose by mouth after appendectomy helps people recover bowel function faster than a placebo.
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Laparoscopic Antibiotic Lavage to Help Prevent Abscess After Complicated Appendicitis
This trial tests whether washing the abdomen with antibiotics during laparoscopic appendectomy can reduce the chance of an intra-abdominal abscess in people with complicated appendicitis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.