The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Study Overview
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Brief Summary
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Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment. A follow up will be conducted  10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.

Official Title
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The Management of Perforated Acute Appendicitis: A Randomized Control Trial in the Adult and Pediatric Populations

Conditions
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Perforated Appendicitis

Intervention / Treatment
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* Procedure: Appendectomy
* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of all ages. Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis. Formal consent for the present study must be signed by the patient or his/her parents Patients with initial presentation of a phlegmon (abscess in evolution) Exclusion Criteria: Patients with non-perforated appendicitis Presentation with initially non-perforated appendicitis but found perforation at surgery Patient with septic shock Patients who had previous appendectomy Current treatment of malignancy Immunocompromised patients Positive pregnancy test No consent for the study
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: Standard pediatric group:<br>patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25) | Procedure: Appendectomy<br>* Interval Appendectomy<br>|
| Experimental: Experimental pediatric group:<br>patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25) | Other: Observation<br>* observation and follow up<br>|
| Active Comparator: Standard adult group:<br>patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25) | Procedure: Appendectomy<br>* Interval Appendectomy<br>|
| Experimental: Experimental adult group:<br>Patients ≥18 yo with acute perforated appendicitis and observation (n=25) | Other: Observation<br>* observation and follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine rate and severity of complications after interval appendectomy |  | 12 months | 
| Determine the incidence and rate of appendectomies (in the observation arm) during the first year of diagnosis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate of complete response after percutaneous drainage and antibiotic therapy |  | 12 months | 
| Determine the mean surgical value (quality/cost) for each group |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforated appendicitis, Pediatric appendicitis, Appendectomy, Appendiceal abscess, Antibiotic Therapy