Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Study Overview
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Brief Summary
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Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. There have been some encouraging reports on successful treatment of appendicitis with antibiotics and it has been estimated that operative treatment might be necessary for only 15 - 20 % of patients with acute appendicitis. The aim of this randomized prospective study is to compare operative treatment (open appendicectomy) with conservative treatment with antibiotics (ertapenem, Invanz). Before randomization acute uncomplicated appendicitis is diagnosed with a CT scan.The hypothesis of the study is that the majority of patients with uncomplicated acute appendicitis can be treated successfully with antibiotics and unnecessary appendicectomies can be avoided.

Official Title
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Study of Surgical Treatment (Open Appendicectomy) Versus Antibiotic Treatment (Ertapenem) in the Treatment of Acute Uncomplicated Appendicitis

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: Appendicectomy
* Drug: Ertapenem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 18 to 60 years CT scan diagnosed uncomplicated acute appendicitis Exclusion Criteria: Age under 18 years or age over 60 years Pregnancy or breast-feeding Allergy to contrast media or iodine Renal insufficiency metformin medication (DM) Peritonitis (a perforated appendix) Lack of co-operation (unable to give consent) A severe other medical condition CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Operative treatment<br>Regular open appendicectomy | Procedure: Appendicectomy<br>* Standard appendicectomy<br>|
| Active Comparator: Antibiotic treatment<br>Ertapenem 1 g i.v. x 1 three days | Drug: Ertapenem<br>* ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis | A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment |  | 1 year | 
| The Direct and Indirect Costs of Both Treatment Arms |  | 1 year | 
| The Recurrence of Conservatively Treated Appendicitis |  | up to 10 years |