Antibiotics Versus Surgery in Acute Appendicitis (ASAA)
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.
Acute Appendicitis Without Peritonitis
|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|
- 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 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 ]
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.
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.
|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)|
Ertapenem i.v,m 1g, once a day, 3 days
Active Comparator: appendectomy
Appendectomy is compared to Ertapenem
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421901
|Contact: Michele Pisano, Principal investigator||0039 firstname.lastname@example.org|
|1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo||Recruiting|
|Bergamo, Italy, 24127|
|Study Director:||Luca Ansaloni||Papa Giovanni XXIII Hospital Bergamo|
|Principal Investigator:||Michele Pisano||Papa Giovanni XXIII Hospital Bergamo|