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Antibiotics Versus Surgery in Acute Appendicitis (ASAA)

This study is currently recruiting participants.
Verified August 2011 by Ospedali Riuniti di Bergamo
Sponsor:
Information provided by (Responsible Party):
Michele Pisano, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:
NCT01421901
First received: August 4, 2011
Last updated: August 20, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Appendicitis Without Peritonitis
 Drug: Ertapenem
Procedure: appendectomy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedali Riuniti di Bergamo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 218
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ertapenem Drug: Ertapenem
Ertapenem i.v,m 1g, once a day, 3 days
Active Comparator: appendectomy
Appendectomy is compared to Ertapenem
 Procedure: appendectomy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421901

Contacts
Contact: Michele Pisano, Principal investigator 0039 0352667166 mpisano@ospedaliriuniti.bergamo

Locations
Italy
1St General Surgery Unit Ospedali Riuniti di Bergamo Recruiting
Bergamo, Italy, 24128
Sponsors and Collaborators
Ospedali Riuniti di Bergamo
Investigators
Study Director: Luca Ansaloni Ospedali Riuniti di Bergamo
Principal Investigator: Michele Pisano Ospedali Riuniti di Bergamo
  More Information

No publications provided

Responsible Party: Michele Pisano, Medical Doctor, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier: NCT01421901     History of Changes
Other Study ID Numbers: EUDRA CT Number 2011-002977-44
Study First Received: August 4, 2011
Last Updated: August 20, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Ospedali Riuniti di Bergamo:
Acute appendicitis
Surgery
Antibiotics
comparison surgery and antibiotics
resolutions of symptoms

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Peritonitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
 Disease Attributes
Pathologic Processes
Peritoneal Diseases
Anti-Bacterial Agents
Ertapenem
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013