Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
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.
Appendectomy is the most frequent intra-abdominal operation performed, accounting for the
 majority of admissions in a general surgery unit. Appendectomy has always been considered the
 cornerstone in the treatment of acute appendicitis.Nevertheless, the idea of a conservative
 treatment using antibiotics is not that recent. Current practices have proven the efficiency
 of antibiotic therapy in treating certain infectious abdominal conditions including:
 appendicular mass with or without periappendicular abscess and acute diverticulitis. This
 success has prompted the researchers to consider the exclusive use of antibiotic therapy in
 the treatment of non complicated appendicitis.

 In patients with clinical suspicion of acute appendicitis (localized abdominal tenderness,
 inflammatory reaction...etc) a CT scan will be performed to confirm the diagnosis of non
 complicated appendicitis. This diagnosis is confirmed on the CT in the absence of any sign of
 either localized peritonitis, and/or perforation (extraluminal gas, appendicular abscess, or
 phlegmon).

 After a thorough explanation of this study, the patient will be obliged to sign a written
 consent. Patients will be randomly assigned to either one of the two therapeutic modalities :
 an appendectomy,or an antibiotic treatment consisting of amoxicillin and clavulanate
 potassium.

 This therapy will be continued until the normalisation of leucocytic count and C reactive
 protein are achieved. In order to demonstrate equivalent conclusive results comparing the two
 treatment modalities, the statistical consultant estimated the inclusion of at least 200
 patients in the study. However, after considering the possible loss of a number of patients
 following their inclusion for a variety of reasons, it was decided that a total of 250
 patients will be enrolled.

 Rate of intra abdominal infections in both therapeutic strategies is the first endpoint to be
 compared. Duration of pain, diet, hospitalisation, absence from work will also be compared.
 In the group of patients treated by antibiotics, the rate of persistant and recurrent
 appendicitis after treatment will be evaluated. Recurrent appendicitis is not considered a
 complication as long as the recurrence of the appendicitis is uncomplicated. During the
 followup period of one year, long-term complications will be observed including: abdominal
 hernia, adhesive intestinal occlusion, and others.
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