Antibiotics Versus Surgery in Acute Appendicitis (ASAA)
Primary Purpose
Acute Appendicitis Without Peritonitis
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ertapenem
appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Appendicitis Without Peritonitis focused on measuring Acute appendicitis, Surgery, Antibiotics, comparison surgery and antibiotics, resolutions of symptoms
Eligibility 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.
Sites / Locations
- 1St General Surgery Unit Papa Giovanni XXIII Hospital BergamoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ertapenem
appendectomy
Arm Description
Appendectomy is compared to Ertapenem
Outcomes
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
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
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.
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.
Full Information
NCT ID
NCT01421901
First Posted
August 4, 2011
Last Updated
June 16, 2014
Sponsor
A.O. Ospedale Papa Giovanni XXIII
1. Study Identification
Unique Protocol Identification Number
NCT01421901
Brief Title
Antibiotics Versus Surgery in Acute Appendicitis
Acronym
ASAA
Official Title
Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis Without Peritonitis
Keywords
Acute appendicitis, Surgery, Antibiotics, comparison surgery and antibiotics, resolutions of symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ertapenem
Arm Type
Experimental
Arm Title
appendectomy
Arm Type
Active Comparator
Arm Description
Appendectomy is compared to Ertapenem
Intervention Type
Drug
Intervention Name(s)
Ertapenem
Intervention Description
Ertapenem i.v,m 1g, once a day, 3 days
Intervention Type
Procedure
Intervention Name(s)
appendectomy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year
Description
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.
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.
Time Frame
2 weeks- One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Pisano, Principal investigator
Phone
0039 0352673412
Email
mpisano@hpg23.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Ansaloni
Organizational Affiliation
Papa Giovanni XXIII Hospital Bergamo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michele Pisano
Organizational Affiliation
Papa Giovanni XXIII Hospital Bergamo
Official's Role
Principal Investigator
Facility Information:
Facility Name
1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Antibiotics Versus Surgery in Acute Appendicitis
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