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Antibiotics Versus Surgery in Acute Appendicitis

NCT01421901 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2014-06-17

No results posted yet for this study

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

  • Acute Appendicitis Without Peritonitis

Interventions

DRUG

Ertapenem

Ertapenem i.v,m 1g, once a day, 3 days

PROCEDURE

appendectomy

Sponsors & Collaborators

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Luca Ansaloni · Papa Giovanni XXIII Hospital Bergamo

  • Michele Pisano · Papa Giovanni XXIII Hospital Bergamo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01421901 on ClinicalTrials.gov