Antibiotic Therapy Versus Appendectomy for Acute Appendicitis

NCT ID: NCT00135603

Last Updated: 2009-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

appendectomy, actual usual treatment

Group Type: ACTIVE_COMPARATOR

appendectomy

Intervention Type: PROCEDURE

ablation of the appendix by laparotomy or laparoscopy

B

antibiotic therapy

Group Type: ACTIVE_COMPARATOR

amoxicillin/clavulanate potassium

Intervention Type: DRUG

1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks

Interventions

amoxicillin/clavulanate potassium

1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks

Intervention Type: DRUG

appendectomy

ablation of the appendix by laparotomy or laparoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical suspicion of appendicitis
• Age more than 18 years

• Appendix diameter > 6 mm

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:

• Appendix non visualised
• Signs of localized peritonitis:

• extradigestive gas
• fluid collection around the appendix
• generalized intraperitoneal fluid

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Assistance Publique Hôpitaux de Paris

Principal Investigators

Corinne Vons, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Antoine Béclère Hospital - Department of Surgery

Clamart, , France

Henri Mondor Hospital

Créteil, , France

Hotel Dieu Hospital, Department of Digestive Surgery

Paris, , France

Cochin Hospital, Department of Digestive Surgery

Paris, , France

Lariboisière Hospital, Department of Digestive Surgery

Paris, , France

Countries

France

References

Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

Reference Type: DERIVED

PMID: 21550483 (View on PubMed)

Other Identifiers

AOR 02063

Identifier Type: -

Identifier Source: secondary_id

P020915

Identifier Type: -

Identifier Source: org_study_id