Prospective clinical trial: antibiotic treatment of non-complicated acute appendicitis in childre

Not Applicable

Recruiting

• Conditions: K35.8; Acute appendicitis, other and unspecified

• Registration Number: DRKS00034038
• Lead Sponsor: niv. Klinik für Kinder und Jugendchirurgie, Medizinische Universität Wien, Wien, Österreich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

patients between 6-18 years of age
- sonographically diagnosed non-complicated acute appendicitis: absence of pericecal fluid, or abscess, prominent pericecal fat inflammation and absence of appendicolith.
- under written consent

Exclusion Criteria

- patients < 6 years of age
- sonographically diagnosed complicated acute appendicitis: loculated pericecal fluid or absess, prominent pericecal fat inflammation and circumferential loss of the submucosal layer
- presence of appedicolith
- major comorbities or previous abdominal operations
- out-patient clinic management not possible (uncompliace of patient and/or family)
- oral antibiotic therapy not possible
- absence of written consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the success rate of non-operative management of non-complicated acute appendicitis in children treated with oral antibiotics in an out-patient clinical setting in comparison to early appendectomy.<br>The primary outcome will be analysed on a non-inferiority basis using a 20% non inferiority margin. The outcomes will be evaluated 1 year after inclusion in the study.