Antibiotics Versus Surgery in Acute Appendicitis (ASAA)

June 16, 2014 updated by: Michele Pisano, A.O. Ospedale Papa Giovanni XXIII

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

218

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michele Pisano, Principal investigator
  • Phone Number: 0039 0352673412
  • Email: mpisano@hpg23.it

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • 1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ertapenem
Drug: Ertapenem
Ertapenem i.v,m 1g, once a day, 3 days
ACTIVE_COMPARATOR: appendectomy
Appendectomy is compared to Ertapenem
Procedure: appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
Time Frame: 2 weeks- One year

  1. Surgery:

    Rate of reintervention due to bowel occlusion (idro fluid level at Abdomen xRay and/no resolution by Gasytograffin) or intraperitoneal abscess; incisional hernia or wound dehiscence.

  2. Antibiotic:

Rate of Diagnosis of new AA. We will register also the rate of intervention for bowel occlusion longer than 48 hours (no passage of flatus, vomit or combination) or intraperitoneal abscess.

Further secondary outcome are Wound infection, negative appendectomy. Hospital stay and work absence.
2 weeks- One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Investigators

  • Study Director: Luca Ansaloni, Papa Giovanni XXIII Hospital Bergamo
  • Principal Investigator: Michele Pisano, Papa Giovanni XXIII Hospital Bergamo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 20, 2011

First Posted (ESTIMATE)

August 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRA CT Number 2011-002977-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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