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Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, June 2005

Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00135603
  Purpose

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 following 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.


Condition Intervention
Appendicitis
Drug: amoxicillin/clavulanate potassium
Procedure: appendectomy
Procedure: computed tomography (CT) scanning

MedlinePlus related topics:   Antibiotics    Appendicitis    Nuclear Scans   

ChemIDplus related topics:   Amoxicillin    Amoxicillin sodium    Amoxicillin trihydrate    Potassium chloride    Clavulanic acid    Clavulanate potassium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:   A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • rate of intra abdominal infections following both therapeutic strategies

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   250
Study Start Date:   February 2004
Estimated Study Completion Date:   February 2007

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 following 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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135603

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

Locations
France
Antoine Béclère Hospital - Department of Surgery     Recruiting
      Clamart, France, 92141 cedex
      Contact: Corinne Vons, MD, PhD     33145374545     corinne.vons@abc.ap-hop-paris.fr    
      Principal Investigator: Corinne Vons, Md PhD            
      Sub-Investigator: Claude Smadja, MD PhD            
      Sub-Investigator: Yan Proske, MD            
      Sub-Investigator: Alessio Carloni, MD            
      Sub-Investigator: Ibrahim Dagher, MD PhD            
      Sub-Investigator: Delphine Poussin, MD            
      Sub-Investigator: Ruben Balzarotti, MD            
Lariboisière Hospital, Department of Digestive Surgery     Recruiting
      Paris, France, 75475
      Contact: Philippe Taleb, MD     33149956565     philippe.taleb@lrb.ap-hop-paris.fr    
      Principal Investigator: Arnaud Alves, MD            
      Principal Investigator: Philippe Taleb, MD            
      Sub-Investigator: Patrice Valleur, MD            
      Sub-Investigator: Yves Panis, MD PhD            
Cochin Hospital, Department of Digestive Surgery     Recruiting
      Paris, France, 75014
      Contact: Thillois Jean Marc, MD     33158414141     jean-marc.thillois@cch.ap-hop-paris.fr    
      Principal Investigator: Jean-Marc Thillois, MD            
      Sub-Investigator: Olivier Soubrane, MD PhD            
      Sub-Investigator: Bertrand Dousset, MD PhD            
      Sub-Investigator: Philippe Bonnichon, MD            
      Sub-Investigator: Pierre Philippe Massault, MD            
      Principal Investigator: Sylvie Gueroult, MD            
      Sub-Investigator: Rémi Cerceau, MD            
      Sub-Investigator: Bruno Randone, MD            
Henri Mondor Hospital     Active, not recruiting
      Creteil, France, 94
Bicêtre Hospital, Department of Digestive Surgery     Suspended
      "Kremlin Bicêtre", France, 94275
Hotel Dieu Hospital, Department of Digestive Surgery     Recruiting
      Paris, France, 75004
      Contact: Stéphane Servajean, MD     33142348234     stephane.servajean@htd.ap-hop-paris.fr    
      Principal Investigator: Stéphane Servajean, MD            
      Sub-Investigator: Jean-Luc Bouillot, MD            

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Investigators
Principal Investigator:     Corinne Vons, MD,PhD     AP-HP    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   P020915, AOR 02063
First Received:   August 24, 2005
Last Updated:   February 1, 2006
ClinicalTrials.gov Identifier:   NCT00135603
Health Authority:   France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
appendicitis.  
adult.  
treatment.  
antibiotic therapy.  
CT scanning.
randomized trial
safety

Study placed in the following topic categories:
Amoxicillin
Digestive System Diseases
Gastrointestinal Diseases
Clavulanic Acid
Appendicitis
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Cecal Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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