Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis

Phase 1

Conditions: ncomplicated acute appendicitis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2023-506213-21-00

Lead Sponsor: Turku University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 498

Inclusion Criteria

Signed informed consent, Age 18–60 years, CT scan confirmed diagnosis of uncomplicated acute appendicitis

Exclusion Criteria

Complicated acute appendicitis on CT (presence of appendicolith, perforation, abscess, suspicion of tumor, or appendiceal diameter 15 mm or greater), Body temperature > 38°C, Age younger than 18 or older than 60 years, Contraindications for CT (pregnancy, lactation, allergy to contrast media or iodine, renal insufficiency with serum creatinine exceeding upper reference limit, type 2 diabetes and metformin medication), Severe systemic illness (malignancy, or requiring immunosuppressant medication), Inability to co-operate and give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can antibiotics be omitted in the treatment of uncomplicated acute appendicitis?;Secondary Objective: Is outpatient treatment of uncomplicated acute appendicitis safe – can hospitalization be avoided?, What are the effects of oral antibiotics on gut microbiota and antibiotic resistance? – Patience safety approach (Microbiology APPAC II);Primary end point(s): 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 Outcome Measures

Name	Time	Method
Secondary end point(s):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