The study is an intention to treat prospective randomized controlled study; due to the characteristic of the study (surgery vs. no surgery) it is no blind for the patients as well for the surgeo

Conditions: All the patients between 18 and 65 years old admitted to the hospital with a first episode of suspected acute appendicitis diagnosed by Andersson's score
MedDRA version: 14.1Level: LLTClassification code 10000677Term: Acute appendicitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-002977-44-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All the patients between 18 and 65 years old admitted to the hospital with a first episode of suspected acute appendicitis diagnosed by Andersson's score
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 218
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient with any potential immunodeficiency status (diseases or syndromes, neoplasia in the last five years), 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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study is an intention to trat prospective randomized controlled study; due to the characteristic of the study (surgery vs. no surgery) it is no blind for the patients as well for the surgeon.;Secondary Objective: N.A;Primary end point(s): Evaluation in both arms of 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;Timepoint(s) of evaluation of this end point: Two weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes will be considered major complication occuring after 2 weeks ant into 1 year. Moreover secondary outcomes will bel considered any minor complications at any time: wound infection, negative appendectomy. Secondary outcomes will be also considered hospital stay and work absence.;Timepoint(s) of evaluation of this end point: Beetwen two weeks and one year.