Clinical Trials Directory

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UnknownNCT01421901

Antibiotics Versus Surgery in Acute Appendicitis

Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
218 (estimated)
Sponsor
A.O. Ospedale Papa Giovanni XXIII · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGErtapenemErtapenem i.v,m 1g, once a day, 3 days
PROCEDUREappendectomy

Timeline

Start date
2011-08-01
Primary completion
2014-12-01
Completion
2015-06-01
First posted
2011-08-23
Last updated
2014-06-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01421901. Inclusion in this directory is not an endorsement.