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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00135603 |
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 |
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Appendicitis |
Drug: amoxicillin/clavulanate potassium Procedure: appendectomy Procedure: computed tomography (CT) scanning |
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 |
Estimated Enrollment: | 250 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Before CT scanning
Inclusion Criteria:
Exclusion Criteria:
CT scanning:
Inclusion Criteria:
Exclusion Criteria:
Signs of localized peritonitis:
Contact: Corinne Vons, MD,PhD | 33145374545 | corinne.vons@abc.ap-hop-paris.fr |
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 |
Principal Investigator: | Corinne Vons, MD,PhD | AP-HP |
Study ID Numbers: | P020915, AOR 02063 |
Study First Received: | August 24, 2005 |
Last Updated: | February 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00135603 |
Health Authority: | France: Ministry of Health |
appendicitis. adult. treatment. antibiotic therapy. |
CT scanning. randomized trial safety |
Amoxicillin Digestive System Diseases Gastrointestinal Diseases Clavulanic Acid Appendicitis |
Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Intestinal Diseases Gastroenteritis |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Pharmacologic Actions Cecal Diseases |