Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00135603

Collaborator

(none)

243

Enrollment

Locations

Arms

Duration (Months)

48.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

rate of intra abdominal infections in both therapeutic strategies [30 days]

Secondary Outcome Measures

duration of pain [30 days]
duration of hospitalisation [30 days]
duration of absence from work [30 days]
rate of wound infection [30 days]
recurrence of appendicitis [12 months]
rate of abdominal hernia [12 months]
rate of adhesive intestinal occlusion [12 months]
cost [30 days and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Antoine Béclère Hospital - Department of Surgery	Clamart	France	92141 cedex
2	Henri Mondor Hospital	Creteil	France	94
3	Hotel Dieu Hospital, Department of Digestive Surgery	Paris	France	75004
4	Cochin Hospital, Department of Digestive Surgery	Paris	France	75014
5	Lariboisière Hospital, Department of Digestive Surgery	Paris	France	75475