Antibiotics Versus Surgery in Acute Appendicitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Appendicitis Without Peritonitis

Intervention / Treatment
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* Drug: Ertapenem
* Procedure: appendectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ertapenem<br> | Drug: Ertapenem<br>* Ertapenem i.v,m 1g, once a day, 3 days<br>|
| Active Comparator: appendectomy<br>Appendectomy is compared to Ertapenem | Procedure: appendectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute appendicitis, Surgery, Antibiotics, comparison surgery and antibiotics, resolutions of symptoms