Clinical trial NCT00135603: Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
Official title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: appendicitis.
adult.
treatment.
antibiotic therapy.
CT scanning.
randomized trial
safety
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: rate of intra abdominal infections in both therapeutic strategies
timeFrame: 30 days
Secondary outcomes:
measure: duration of pain
timeFrame: 30 days
measure: duration of hospitalisation
timeFrame: 30 days
measure: duration of absence from work
timeFrame: 30 days
measure: rate of wound infection
timeFrame: 30 days
measure: recurrence of appendicitis
timeFrame: 12 months
measure: rate of abdominal hernia
timeFrame: 12 months
measure: rate of adhesive intestinal occlusion
timeFrame: 12 months
measure: cost
timeFrame: 30 days and 12 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine Béclère Hospital - Department of Surgery
city: Creteil
country: France
facility: Henri Mondor Hospital
city: Paris
country: France
facility: Hotel Dieu Hospital, Department of Digestive Surgery
city: Paris
country: France
facility: Cochin Hospital, Department of Digestive Surgery
city: Paris
country: France
facility: Lariboisière Hospital, Department of Digestive Surgery
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Corinne Vons, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.