Antibiotics Versus Surgery in Acute Appendicitis
Information source: A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Appendicitis Without Peritonitis
Intervention: Ertapenem (Drug); appendectomy (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: A.O. Ospedale Papa Giovanni XXIII Official(s) and/or principal investigator(s):
Luca Ansaloni, Study Director, Affiliation: Papa Giovanni XXIII Hospital Bergamo
Michele Pisano, Principal Investigator, Affiliation: Papa Giovanni XXIII Hospital Bergamo
Overall contact:
Michele Pisano, Principal investigator, Phone: 0039 0352673412, Email: mpisano@hpg23.it
Summary
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.
Clinical Details
Official title: Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the rate of patients free of symptoms into 2 weeks (from operation in the surgery group or from the third Ertapenem administration in the antibiotics group) with no pain, no fever, WBC ≤ 10000, CRP ≤ 1
Secondary outcome: Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Michele Pisano, Principal investigator, Phone: 0039 0352673412, Email: mpisano@hpg23.it
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo, Bergamo 24127, Italy; Recruiting
Additional Information
Starting date: August 2011
Last updated: June 16, 2014
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