Antibiotics Versus Surgery in Acute Appendicitis

NCT ID: NCT01421901

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Appendicitis Without Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ertapenem

Group Type EXPERIMENTAL

Ertapenem

Intervention Type DRUG

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

appendectomy

Appendectomy is compared to Ertapenem

Group Type ACTIVE_COMPARATOR

appendectomy

Intervention Type PROCEDURE

Interventions

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Ertapenem

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

Intervention Type DRUG

appendectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role lead

Responsible Party

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Michele Pisano

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Ansaloni

Role: STUDY_DIRECTOR

Papa Giovanni XXIII Hospital Bergamo

Michele Pisano

Role: PRINCIPAL_INVESTIGATOR

Papa Giovanni XXIII Hospital Bergamo

Locations

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1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo

Bergamo, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Michele Pisano, Principal investigator

Role: CONTACT

0039 0352673412

Other Identifiers

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EUDRA CT Number 2011-002977-44

Identifier Type: -

Identifier Source: org_study_id

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