Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135603
• Other study ID #: P020915
• Secondary ID: AOR 02063
• Status: Completed
• Phase: N/A
• First received: August 24, 2005
• Last updated: February 11, 2009
• Start date: February 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

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

Procedure:
• appendectomy
ablation of the appendix by laparotomy or laparoscopy

Locations

Country	Name	City	State
France	Antoine Béclère Hospital - Department of Surgery	Clamart
France	Henri Mondor Hospital	Creteil
France	Cochin Hospital, Department of Digestive Surgery	Paris
France	Hotel Dieu Hospital, Department of Digestive Surgery	Paris
France	Lariboisière Hospital, Department of Digestive Surgery	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of intra abdominal infections in both therapeutic strategies		30 days	Yes
Secondary	duration of pain		30 days	No
Secondary	duration of hospitalisation		30 days	No
Secondary	duration of absence from work		30 days	No
Secondary	rate of wound infection		30 days	No
Secondary	recurrence of appendicitis		12 months	No
Secondary	rate of abdominal hernia		12 months	No
Secondary	rate of adhesive intestinal occlusion		12 months	No
Secondary	cost		30 days and 12 months	No