Antibiotics Versus Surgery in Acute Appendicitis

Phase 4UnknownNCT01421901

A.O. Ospedale Papa Giovanni XXIII218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

218

Conditions

Acute Appendicitis Without Peritonitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary outcomes will be considered major complications occurring after 2 weeks and into 1 year. Phone consultation will be performed at 1 year

1. 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. 2. 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.

Time frame: 2 weeks- One year