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. 250 patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections following both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from workover, and during a follow up period of one year, parietal and abdominal complications and recurrrent appendicitis after antibiotic therapy.

Condition	Intervention
Appendicitis	Drug: amoxicillin/clavulanate potassium  Procedure: appendectomy  Procedure: CT scanning

Further Study Details: 

Primary Outcomes: rate of intra abdominal infections following both therapeutic strategies
Secondary Outcomes: duration of pain; duration of hospitalisation; duration of absence from work; rate of wound infection; recurrence of appendicitis; rate of abdominal hernia; rate of adhesive intestinal occlusion; cost
Expected Total Enrollment:  250

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 prompt us 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 scanning 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, our 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 to be enrolled.

Rate of intra abdominal infections following both therapeutic strategies is the first endpoint to be compared. Duration of pain, diet, hospitalisation, absence from work wil be also compared. In the group of patients treated by antibiotics, the rate of recurrent appendicitis after treatment will be evaluated, but 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 lactamines 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00135603

Corinne Vons, MD,PhD      33145374545    corinne.vons@abc.ap-hop-paris.fr

France
      Antoine Béclère Hospital - Department of Surgery, Clamart,  92141 cedex,  France; Recruiting
      Lariboisière Hospital, Department of Digestive Surgery, Paris,  75475,  France; Recruiting
      Cochin Hospital, Department of Digestive Surgery, Paris,  75014,  France; Recruiting
      Hotel Dieu Hospital, Department of Digestive Surgery, Paris,  75004,  France; Recruiting
      Bicêtre Hospital, Department of Digestive Surgery, "Kremlin Bicêtre",  94275,  France; Suspended
      Henri Mondor Hospital, Creteil,  94,  France; No longer recruiting

Study chairs or principal investigators

Corinne Vons, MD,PhD,  Principal Investigator,  AP-HP   

Study ID Numbers:  P020915; AOR 02063
Last Updated:  August 25, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00135603
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-30