Antibiotics Versus Surgery in Acute Appendicitis
ASAA
Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
1 other identifier
interventional
218
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 17, 2014
June 1, 2014
3.3 years
August 4, 2011
June 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
2 weeks
Secondary Outcomes (1)
Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
2 weeks- One year
Study Arms (2)
Ertapenem
EXPERIMENTALappendectomy
ACTIVE COMPARATORAppendectomy is compared to Ertapenem
Interventions
Eligibility Criteria
You may qualify if:
- patients between 18 and 65 years old
- first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo
Bergamo, 24127, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luca Ansaloni
Papa Giovanni XXIII Hospital Bergamo
- PRINCIPAL INVESTIGATOR
Michele Pisano
Papa Giovanni XXIII Hospital Bergamo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 23, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
June 17, 2014
Record last verified: 2014-06