Conservative Treatment of Acute Appendicitis in Children

Study Overview
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Brief Summary
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This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.

Official Title
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Conservative Treatment of Acute Appendicitis in Children Pilot Trial

Conditions
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Child, Appendicitis

Intervention / Treatment
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* Procedure: Appendectomy
* Drug: Conservative, non-surgical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention Exclusion Criteria: Suspicion of perforated appendicitis on the basis of generalized peritonitis An appendiceal mass, diagnosed either by palpation or with radiology

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: Appendectomy<br>Standard surgical treatment, appendectomy | Procedure: Appendectomy<br>* Standard surgical treatment, normally laparoscopic appendectomy<br>* Other names: Laparoscopic appendectomy;|
| Experimental: Conservative, non-surgical treatment<br>Non-operative treatment with intravenous and oral antibiotics | Drug: Conservative, non-surgical treatment<br>* Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.<br>* Other names: Ciprofloxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of symptoms without significant complications | This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in hospital | Number of days as inpatients after initiation of allocated treatment, ea. after randomization. | 7 days | 
| Time to resolution of symptoms | In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia. | 7 days | 
| Abscess formation | As noted either in hospital or during follow up. | 7 days | 
| Early complications | Wound infections, wound dehiscence, diarrhea etc. | 7 days | 
| Pain | Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appendectomy, Nonsurgical treatment with antibiotics