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Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Appendicitis

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

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Corinne Vons, MD,PhD, Principal Investigator, Affiliation: AP-HP

Overall contact:
Corinne Vons, MD,PhD, Phone: 33145374545, Email: corinne.vons@abc.ap-hop-paris.fr

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 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.

Clinical Details

Official title: A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: rate of intra abdominal infections following both therapeutic strategies

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Antoine BĂ©clĂšre Hospital - Department of Surgery, Clamart 92141 cedex, France; Recruiting
Corinne Vons, MD, PhD, Phone: 33145374545, Email: corinne.vons@abc.ap-hop-paris.fr
Corinne Vons, Md PhD, Principal 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, Sub-Investigator

LariboisiĂšre Hospital, Department of Digestive Surgery, Paris 75475, France; Recruiting
Philippe Taleb, MD, Phone: 33149956565, Email: philippe.taleb@lrb.ap-hop-paris.fr
Arnaud Alves, MD, Principal Investigator
Philippe Taleb, MD, Principal Investigator
Patrice Valleur, MD, Sub-Investigator
Yves Panis, MD PhD, Sub-Investigator

Cochin Hospital, Department of Digestive Surgery, Paris 75014, France; Recruiting
Thillois Jean Marc, MD, Phone: 33158414141, Email: jean-marc.thillois@cch.ap-hop-paris.fr
Jean-Marc Thillois, MD, Principal Investigator
Olivier Soubrane, MD PhD, Sub-Investigator
Bertrand Dousset, MD PhD, Sub-Investigator
Philippe Bonnichon, MD, Sub-Investigator
Pierre Philippe Massault, MD, Sub-Investigator
Sylvie Gueroult, MD, Principal Investigator
RĂ©mi Cerceau, MD, Sub-Investigator
Bruno Randone, MD, Sub-Investigator

Hotel Dieu Hospital, Department of Digestive Surgery, Paris 75004, France; Recruiting
Stéphane Servajean, MD, Phone: 33142348234, Email: stephane.servajean@htd.ap-hop-paris.fr
Stéphane Servajean, MD, Principal Investigator
Jean-Luc Bouillot, MD, Sub-Investigator

BicĂȘtre Hospital, Department of Digestive Surgery, "Kremlin BicĂȘtre" 94275, France; Suspended

Henri Mondor Hospital, Creteil 94, France; Active, not recruiting

Additional Information

Starting date: February 2004
Ending date: February 2007
Last updated: February 1, 2006

Page last updated: November 03, 2008

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