ASAA: Antibiotics Versus Surgery in Acute Appendicitis

Sponsor

A.O. Ospedale Papa Giovanni XXIII (Other)

Overall Status

Unknown status

CT.gov ID

NCT01421901

Collaborator

(none)

218

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis Without Peritonitis	Drug: Ertapenem Procedure: appendectomy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ertapenem	Drug: Ertapenem Ertapenem i.v,m 1g, once a day, 3 days
Active Comparator: appendectomy Appendectomy is compared to Ertapenem	Procedure: appendectomy

Arm

Intervention/Treatment

Experimental: Ertapenem

Drug: Ertapenem

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

Active Comparator: appendectomy

Appendectomy is compared to Ertapenem

Procedure: appendectomy

Outcome Measures

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 [2 weeks]

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 [2 weeks- One 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.