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Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics

NCT05761080 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 772

Last updated 2026-03-20

No results posted yet for this study

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).

Conditions

  • Laparoscopic Appendectomy
  • Complicated Appendicitis
  • Periappendicular Abscess

Interventions

DRUG

Oral amoxicillin-clavulanic acid (40mg/kg in 3 times/day; maximum dose 3g/day)

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

DRUG

Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center

Inpatient postpoperative intravenous antibiotic treatment according to the established protocol in each center for 5 days

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Maria Jose Martinez-Zapata, MD, PhD · Institut de Recerca Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761080 on ClinicalTrials.gov