Antibiotic Therapy Versus Appendectomy for Acute Appendicitis
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Purpose
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 | Intervention |
|---|---|
|
Appendicitis |
Drug: amoxicillin/clavulanate potassium Procedure: appendectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis |
- rate of intra abdominal infections in both therapeutic strategies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- duration of pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- duration of hospitalisation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- duration of absence from work [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- rate of wound infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- recurrence of appendicitis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- rate of abdominal hernia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- rate of adhesive intestinal occlusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- cost [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 243 |
| Study Start Date: | February 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| France | |
| Antoine Béclère Hospital - Department of Surgery | |
| Clamart, France, 92141 cedex | |
| Henri Mondor Hospital | |
| Creteil, France, 94 | |
| Lariboisière Hospital, Department of Digestive Surgery | |
| Paris, France, 75475 | |
| Cochin Hospital, Department of Digestive Surgery | |
| Paris, France, 75014 | |
| Hotel Dieu Hospital, Department of Digestive Surgery | |
| Paris, France, 75004 | |
| Principal Investigator: | Corinne Vons, MD,PhD | AP-HP |
More Information
No publications provided by Assistance Publique - Hôpitaux de Paris
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Corinne VONS, MD, PhD, Assistance Publique Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00135603 History of Changes |
| Other Study ID Numbers: | P020915, AOR 02063 |
| Study First Received: | August 24, 2005 |
| Last Updated: | February 11, 2009 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
appendicitis. adult. treatment. antibiotic therapy. |
CT scanning. randomized trial safety |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes Amoxicillin |
Anti-Bacterial Agents Amoxicillin-Potassium Clavulanate Combination Clavulanic Acids Clavulanic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013