Antibiotics Versus Surgery in Acute Appendicitis (ASAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by A.O. Ospedale Papa Giovanni XXIII
Sponsor:
Information provided by (Responsible Party):
Michele Pisano, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT01421901
First received: August 4, 2011
Last updated: June 16, 2014
Last verified: June 2014
  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:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

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: June 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421901

Contacts
Contact: Michele Pisano, Principal investigator 0039 0352673412 mpisano@hpg23.it

Locations
Italy
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo Recruiting
Bergamo, Italy, 24127
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Michele Pisano, Medical Doctor, A.O. Ospedale Papa Giovanni XXIII
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: June 16, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Acute appendicitis
Surgery
Antibiotics
comparison surgery and antibiotics
resolutions of symptoms

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

ClinicalTrials.gov processed this record on September 16, 2014