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Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00135603
First received: August 24, 2005
Last updated: February 11, 2009
Last verified: January 2009

August 24, 2005
February 11, 2009
February 2004
February 2008   (final data collection date for primary outcome measure)
rate of intra abdominal infections in both therapeutic strategies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
rate of intra abdominal infections following both therapeutic strategies
Complete list of historical versions of study NCT00135603 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Appendicitis
  • Drug: amoxicillin/clavulanate potassium
    1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks
  • Procedure: appendectomy
    ablation of the appendix by laparotomy or laparoscopy
  • Active Comparator: A
    appendectomy, actual usual treatment
    Intervention: Procedure: appendectomy
  • Active Comparator: B
    antibiotic therapy
    Intervention: Drug: amoxicillin/clavulanate potassium
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
December 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00135603
P020915, AOR 02063
Yes
Corinne VONS, MD, PhD, Assistance Publique Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Corinne Vons, MD,PhD AP-HP
Assistance Publique - Hôpitaux de Paris
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP