Early Versus Delayed Operation for Perforated Appendicitis

Study Overview
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Brief Summary
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The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess. The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

Detailed Description
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This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study. Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study. Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.

Official Title
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Early Versus Delayed Operation for Perforated Appendicitis With Abscess, a Pilot Study

Conditions
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Appendiceal Abscess

Intervention / Treatment
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* Procedure: Operation on Admission
* Procedure: Drainage and Interval Appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan. Children of any age will be included. Exclusion Criteria: Patients with immune deficiency Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities). Acute sepsis or severe pain from perforation not allowing for delayed management.

Ages Eligible for Study
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Maximum 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 |
| --- | --- |
| Active Comparator: 1<br>Drainage with interval appendectomy | Procedure: Drainage and Interval Appendectomy<br>* drainage with interval appendectomy<br>|
| Experimental: 2<br>appendectomy on presentation | Procedure: Operation on Admission<br>* Laparoscopic appendectomy on admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIP and PedsQL4 scores, time to full feeds, days of hospitalization, recurrent abscess, number of recurrences, number of CT scans, operating time |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforated Appendicitis, Abscess, Appendectomy