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
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis Without Peritonitis||Drug: Ertapenem Procedure: appendectomy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Ertapenem i.v,m 1g, once a day, 3 days
Active Comparator: appendectomy
Appendectomy is compared to Ertapenem
- 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 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 ]
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.
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
|Contact: Michele Pisano, Principal investigator||0039 email@example.com|
|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|