Is Interval Appendectomy Necessary?

Study Overview
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Brief Summary
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Appendicitis is one of the most common surgical problems in children, with 20-35% of patients having perforated by the time they present to a doctor. In these cases, the patient is often treated non-surgically with antibiotics. Once a patient has improved, it is not known whether it is better to perform an interval appendectomy (IA) or to continue a watchful waiting approach. The purpose of this trial is to determine if expectant nonoperative management (watchful waiting) is not inferior compared to IA management after successful conservative treatment of appendiceal mass at admission.

Official Title
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Interval Appendectomy in Children, is it Really Necessary? A Randomized, Noninferiority Trial

Conditions
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Appendicitis

Intervention / Treatment
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* Procedure: Conservative Management
* Procedure: Operative Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Under 18 years of age Perforated appendicitis where the treating physician chooses to follow the conservative approach rather than performing an immediate appendectomy Exclusion Criteria: Uncertainty about the diagnosis The need for laparotomy/laparoscopy for another reason Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Another medical condition that may affect the decision to operate e.g., inflammatory bowel disease A comorbidity or chronic illness that contraindicates the watchful waiting approach, e.g, diabetes or cardiac problems

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 |
| --- | --- |
| Experimental: Conservative Management<br>Children randomized to conservative management will be seen in the clinic 6-10 weeks after discharge and phoned to follow up every 3 month for a total follow-up of a year. Family will be instructed to come back to the hospital or call the treating physician if the child develops any abdominal pain or fever. | Procedure: Conservative Management<br> <br> |
| Active Comparator: Operative Management<br>Children randomized to IA will be scheduled for an interval appendectomy 6-10 weeks after discharge, and will be seen in the clinic 6-8 weeks following the interval appendectomy and phoned for follow-up every 3 month for a total of one year. | Procedure: Operative Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent appendicitis for the conservative group |  | During a year of follow-up | 
| Operative complications for the operative group |  | During a year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  | This is the patients' original hospital stay, and re-admission for interval appendectomy when applicable, an expected average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Surgery