Study of Conservative Versus Surgical Treatment of Appendicitis

Study Overview
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Brief Summary
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The purpose of this study is to determine if antibiotic treatment of appendicitis is an option compared to surgery. The investigators' hypothesis is that a majority of patients with appendicitis can heal without surgery and that there are several advantages with antibiotic treatment related to time to recover, complications and economical aspects.

Detailed Description
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Appendicitis is a common disease; 1/1000 gets it every year. 7% will get appendicitis during their lifetime. Surgery, open or laparoscopic, is the traditional treatment. A number of these patients don´t have appendicitis when operated on and the operation is therefore unnecessarily performed. It is also a risk for complications after surgery; for instance wound infection, postoperative small bowel obstruction. In our study we will compare antibiotic as the only treatment with traditional surgical treatment. Patients with suspected appendicitis are randomized to either surgery or antibiotics according to their birth date. Patients in the surgery group are treated according to standard routines. Patients in the antibiotic group are treated with intravenous antibiotics for at least 24h - this regime can be prolonged if clinical recovery doesn´t occur - and submitted from hospital with oral antibiotics. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation) they will be operated. Parameters that will be analyzed are: primary healing in the antibiotic group frequency of relapse in appendicitis in the antibiotic group complications in both groups economical analysis (hospital stay, sick leave time, time off work) in both groups

Official Title
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Randomized Study of Conservative Versus Surgical Treatment of Appendicitis; Analyses of Result and Economics

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: cefotaxim and metronidazol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected appendicitis in patients over 18 years Exclusion Criteria: Under 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Op<br>traditional surgery | |
| Experimental: Ab<br>antibiotic treatment | Drug: cefotaxim and metronidazol<br>* iv administration for at least 24 h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment efficacy |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, treatment, antibiotics