Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

Criteria

Before CT scanning

Inclusion Criteria:

• Clinical suspicion of appendicitis

• Age more than 18 years

Exclusion Criteria:

• Clinical signs of generalized peritonitis

• Previous take of antibiotics within the 5 days preceding the presentation

• Allergy or intolerance to lactamases and/or clavulanate potassium

• Corticosteroid or anticoagulant therapy

• Patient with a known inflammatory bowel disease (Crohn's disease or ulcerative colitis)

• Pregnant women

• Patient with iode allergy

• Renal insufficiency (creatinine > 200 )

CT scanning:

Inclusion Criteria:

• Appendix diameter > 6 mm

Exclusion Criteria:

• Appendix non visualised

• Signs of localized peritonitis:

• extradigestive gas

• fluid collection around the appendix

• generalized intraperitoneal fluid