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Optimizing the antibiotic treatment of uncomplicated acute appendicitis: a prospective randomized multicenter study

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518984-36-00
Enrollment
599
Registered
2024-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-20

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

Conditions

Uncomplicated acute appendicitis

Brief summary

The primary endpoint of the APPAC II trial is defined as the success of the randomised treatment at one-year follow-up (treatment efficacy). Treatment success in both groups is defined as the resolution of acute appendicitis with antibiotic treatment resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a follow-up of one year.

Detailed description

Secondary endpoints include post-intervention complications (possible postoperative complications classified using the Clavien-Dindo classification), late recurrence (after one year) of acute appendicitis after antibiotic treatment, duration of hospital stay, VAS scores, quality of life (QOL, using for example 5D or 15D validated QOL questionnaire), length of sick leave and treatment costs.

Interventions

DRUGLEVOFLOXACIN
DRUGERTAPENEM
DRUGMOXIFLOXACIN
DRUGMETRONIDAZOLE

Sponsors

Turku University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the APPAC II trial is defined as the success of the randomised treatment at one-year follow-up (treatment efficacy). Treatment success in both groups is defined as the resolution of acute appendicitis with antibiotic treatment resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a follow-up of one year.

Secondary

MeasureTime frame
Secondary endpoints include post-intervention complications (possible postoperative complications classified using the Clavien-Dindo classification), late recurrence (after one year) of acute appendicitis after antibiotic treatment, duration of hospital stay, VAS scores, quality of life (QOL, using for example 5D or 15D validated QOL questionnaire), length of sick leave and treatment costs.

Countries

Finland

Outcome results

None listed

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