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
  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 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 Intervention
Appendicitis
Drug: amoxicillin/clavulanate potassium
Procedure: appendectomy

Study Type: Interventional
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • rate of intra abdominal infections in both therapeutic strategies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 243
Study Start Date: February 2004
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corinne VONS, MD, PhD, Assistance Publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00135603     History of Changes
Other Study ID Numbers: P020915, AOR 02063
Study First Received: August 24, 2005
Last Updated: February 11, 2009
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014