Antibiotic therapy vs. placebo in the treatment of acute uncomplicated appendicitis: a prospective randomized double-blind placebo-controlled trial - APPAC III

Phase 4

Not yet recruiting

• Conditions: Uncomplicated acute appendicitis

• Registration Number: 2025-520761-44-00
• Lead Sponsor: Turku University Hospital

Brief Summary

The aim of the study is to compare antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis to evaluate the role of antibiotic therapy in the resolution of acute

uncomplicated appendicitis.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

1. Signed informed consent, 2) Age 18 – 60 years, 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis.

Exclusion Criteria

1. Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Renal insufficiency, 5) Allergy or contraindication to antibiotic therapy 6) Metformine medication, 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications), 8) Complicated acute appendicitis in a CT scan (appendicolith, perforation, abscess, suspicion of a tumor), 9) 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
The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.		The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one, three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick leave and treatment costs.		Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one, three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick leave and treatment costs.

Trial Locations

Locations (5)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

HUS-Yhtymae; 🇫🇮 Helsinki, Finland

Kuopio University Hospital

🇫🇮Kuopio, Finland

Tuomo Rantanen

Site contact

017173311

tuomo.rantanen@kuh.fi