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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520777-39-00

Enrollment

772

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated acute appendicitis

Brief summary

The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.

Interventions

DRUGAmoxicilina/Ácido clavulánico NORMON 1.000 mg/200 mg polvo para solución inyectable y para perfusión EFG

DRUGAmoxicilina/Ácido clavulánico NORMON 875 mg/125 mg comprimidos recubiertos con película EFG

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be the composite variable "adverse events" occurring within the first 30 postoperative days, defined as the occurrence of any of the following events: intra-abdominal abscess, peritonitis, surgical wound complications, reoperation, sepsis, or death.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026