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Antibiotics Versus Surgery in Acute Appendicitis (ASAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01421901
Recruitment Status : Unknown
Verified June 2014 by Michele Pisano, A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Recruiting
First Posted : August 23, 2011
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Michele Pisano, A.O. Ospedale Papa Giovanni XXIII

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Appendicitis Without Peritonitis Drug: Ertapenem Procedure: appendectomy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
Study Start Date : August 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421901


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

Locations
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Italy
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo Recruiting
Bergamo, Italy, 24127
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
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Study Director: Luca Ansaloni Papa Giovanni XXIII Hospital Bergamo
Principal Investigator: Michele Pisano Papa Giovanni XXIII Hospital Bergamo
More Information
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Responsible Party: Michele Pisano, Medical Doctor, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT01421901    
Other Study ID Numbers: EUDRA CT Number 2011-002977-44
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014
Keywords provided by Michele Pisano, A.O. Ospedale Papa Giovanni XXIII:
Acute appendicitis
Surgery
Antibiotics
comparison surgery and antibiotics
resolutions of symptoms
Additional relevant MeSH terms:
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Appendicitis
Peritonitis
Acute Disease
Intraabdominal Infections
Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Cecal Diseases
Intestinal Diseases
Peritoneal Diseases
Disease Attributes
Pathologic Processes
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents