Antibiotics Versus Surgery in Acute Appendicitis

Acute Appendicitis Without Peritonitis Clinical Trial

— ASAA  

Official title:

Antibiotics vs.Surgery in Acute Appendicitis;an Intention to Treat Prospective Randomised Study. The ASAA-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01421901
• Other study ID #: EUDRA CT Number 2011-002977-44
• Status: Recruiting
• Phase: Phase 4
• First received: August 4, 2011
• Last updated: June 16, 2014
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2014
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Michele Pisano, Principal investigator
• Phone: 0039 0352673412
• Email: mpisano[@]hpg23.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Appendicitis Without Peritonitis
• Acute Disease
• Appendicitis
• Peritonitis

Intervention

Drug:
• Ertapenem
Ertapenem i.v,m 1g, once a day, 3 days

Procedure:
• appendectomy

Locations

Country	Name	City	State
Italy	1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	2 weeks- One year	No