Uncomplicated acute appendicitis
Conditions
Brief summary
The primary outcome is 30-day treatment success defined as resolution of acute appendicitis resulting in discharge from the hospital without appendectomy during the 30-day follow-up
Detailed description
Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after the 30-day follow-up, duration of hospital stay in hours, admission to hospital and reason for admission, readmissions to emergency department or hospitalization, VAS pain scores, quality of life (QOL, EQ-5D-5L), sick leave and overall treatment and societal costs
Interventions
DRUGActive investigational medicinal product (imp) contains 400 mg of moxifloxacin (1 x 400 mg tablet). moxifloxacin 400 mg tablets
DRUGwhich are authorized medicinal products
DRUGare sourced from legal supply chain of medicinal products at eu and used for preparation of the active imp. tablets are masked by over encapsulation with hard gelatine capsule
DRUG1 x 400 mg in a capsule to maintain blinding. matching placebo imp capsule are prepared containing microcrystalline cellulose.
DRUGMOXIFLOXACIN
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is 30-day treatment success defined as resolution of acute appendicitis resulting in discharge from the hospital without appendectomy during the 30-day follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after the 30-day follow-up, duration of hospital stay in hours, admission to hospital and reason for admission, readmissions to emergency department or hospitalization, VAS pain scores, quality of life (QOL, EQ-5D-5L), sick leave and overall treatment and societal costs | — |
Countries
Finland
Outcome results
None listed