Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135603
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : February 12, 2009
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: amoxicillin/clavulanate potassium Procedure: appendectomy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis
Study Start Date : February 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A
appendectomy, actual usual treatment
Procedure: appendectomy
ablation of the appendix by laparotomy or laparoscopy

Active Comparator: B
antibiotic therapy
Drug: amoxicillin/clavulanate potassium
1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks

Primary Outcome Measures :
  1. rate of intra abdominal infections in both therapeutic strategies [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. duration of pain [ Time Frame: 30 days ]
  2. duration of hospitalisation [ Time Frame: 30 days ]
  3. duration of absence from work [ Time Frame: 30 days ]
  4. rate of wound infection [ Time Frame: 30 days ]
  5. recurrence of appendicitis [ Time Frame: 12 months ]
  6. rate of abdominal hernia [ Time Frame: 12 months ]
  7. rate of adhesive intestinal occlusion [ Time Frame: 12 months ]
  8. cost [ Time Frame: 30 days and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135603

Antoine Béclère Hospital - Department of Surgery
Clamart, France, 92141 cedex
Henri Mondor Hospital
Creteil, France, 94
Hotel Dieu Hospital, Department of Digestive Surgery
Paris, France, 75004
Cochin Hospital, Department of Digestive Surgery
Paris, France, 75014
Lariboisière Hospital, Department of Digestive Surgery
Paris, France, 75475
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Corinne Vons, MD,PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Corinne VONS, MD, PhD, Assistance Publique Hôpitaux de Paris Identifier: NCT00135603     History of Changes
Other Study ID Numbers: P020915
AOR 02063
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: January 2009

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

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action