Acute Appendicitis: Active Observation With and Without Antibiotics

Study Overview
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Brief Summary
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This study evaluates if early provision of antibiotics is a superior treatment compared to traditional wait and see with regard to symptom relief for suspected acute uncomplicated appendicitis.

Detailed Description
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Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence. However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective. The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

Official Title
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Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).
* Other: Active observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with suspected appendicitis. Age<60 years. C-reactive protein < 60 mg/L. White blod cell Count (leucocytes) < 13 e9 /L. Exclusion criteria: Pregnant

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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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
Interventional Model Description: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups Active observation or Antibiotic treatment in a 1:1 ratio.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic treatment<br>Patients will receive in-hospital intravenous antibiotics (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3). Surgery if no symptom relif occur. | Drug: Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).<br>* Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.<br>* Other names: Flagyl;|
| Other: Clinical observation<br>Patients are followed by in-hospital Active observation (watchful waiting) according to clinical routine. Patients are observed until either, recovery and dismissal from hospital, or decision for intervention (surgery) is taken. | Other: Active observation<br>* In-hospital observation without antibiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with no symptom relief | No symptom relief and surgery is deemed necessary. | 48 hours |