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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis|
- rate of intra abdominal infections in both therapeutic strategies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- duration of pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- duration of hospitalisation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- duration of absence from work [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- rate of wound infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- recurrence of appendicitis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- rate of abdominal hernia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- rate of adhesive intestinal occlusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- cost [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A
appendectomy, actual usual treatment
ablation of the appendix by laparotomy or laparoscopy
Active Comparator: B
Drug: amoxicillin/clavulanate potassium
1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135603
|Antoine Béclère Hospital - Department of Surgery|
|Clamart, France, 92141 cedex|
|Henri Mondor Hospital|
|Creteil, France, 94|
|Cochin Hospital, Department of Digestive Surgery|
|Paris, France, 75014|
|Hotel Dieu Hospital, Department of Digestive Surgery|
|Paris, France, 75004|
|Lariboisière Hospital, Department of Digestive Surgery|
|Paris, France, 75475|
|Principal Investigator:||Corinne Vons, MD,PhD||Assistance Publique - Hôpitaux de Paris|