Antibiotics Versus Surgery in Acute Appendicitis

Phase 4

• Conditions: Acute Appendicitis Without Peritonitis
• Interventions: Procedure: appendectomy; Drug: Ertapenem

• Registration Number: NCT01421901
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-20
• Study First Posted: 2011-08-23
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 218

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
appendectomy	appendectomy	Appendectomy is compared to Ertapenem
Ertapenem	Ertapenem	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

1St General Surgery Unit Papa Giovanni XXIII Hospital Bergamo; 🇮🇹 Bergamo, Italy