Antibiotics Versus Surgery in Acute Appendicitis (ASAA)

A.O. Ospedale Papa Giovanni XXIII

Status and phase

Unknown

Phase 4

Conditions

Acute Appendicitis Without Peritonitis

Treatments

Drug: Ertapenem

Procedure: appendectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01421901

EUDRA CT Number 2011-002977-44

Details and patient eligibility

About

The acute appendicitis (AA) is a very common disease with a life time risk 7-8% and the highest incidence in the second decades . The aetiology of AA is still poor understood: the commonest hypothesis refers to appendix obstruction followed by impairment of wall appendix barrier and thus wall perforation and/or abscess formation1. However some studies suggest that no-complicate and complicate appendicitis are different entities allowing a different treatment. The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.The study aims to test the no inferiority in terms of efficacy of antibiotic treatment compared to surgery in a population with high probability to suffer of 1st episode of AA.

Enrollment

218 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients between 18 and 65 years old
first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound

Exclusion criteria

patients with any potential immunodeficiency status
assumption of antibiotics for different infectious disease or surgery in the last 30 days
allergy to antibiotics established in the study protocol
no acceptance of study protocol
pregnancy or delivery in the last 6 months
ASA IV or V, no Italian or English fluently speakers.