Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Study Overview
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Brief Summary
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The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

Detailed Description
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The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation. Patients with pilonidal disease can have significant pain and drainage at the gluteal cleft, and recurrent disease in this teenage and young adult population often leads to social embarrassment, isolation, and time off from work or school. Effective therapy to prevent recurrent disease is urgently needed. The current standard of care is excision of pilonidal cyst. The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision. The research will consist of patient surveys and clinical notes. Surgical excision is not needed to be part of this research. All patients will receive surveys and their charts will be reviewed. At the point of treatment decision making, the patients will be randomized to one of the two options.

Official Title
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Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Conditions
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Pilonidal Disease

Intervention / Treatment
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* Procedure: Regular Epilation Regimen
* Procedure: Surgical excision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at Stanford Healthcare with pilonidal disease. Patients over the age of 8yrs. Exclusion Criteria: Inability to read, write or understand English ***or Spanish Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire

Ages Eligible for Study
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Minimum Age: 8 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular epilation regimen only<br> | Procedure: Regular Epilation Regimen<br>* Epilation using laser device<br>|
| Active Comparator: Regular epilation regimen with surgical excision<br> | Procedure: Regular Epilation Regimen<br>* Epilation using laser device<br>Procedure: Surgical excision<br>* Excision of pilonidal pit with trephine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with recurrent symptoms of pilonidal disease |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants requiring antibiotic treatment |  | Up to 1 year | 
| Time taken off from school or work due to pilonidal disease |  | Up to 1 year | 
| Effect on parent's daily activities | Parents measure the effect of caring for afflicted children on a 0-10 rating scale, higher scores correspond to more difficulties. | Baseline to 1 year | 
| Number of participants requiring additional surgical intervention |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilonidal Surgery, Pilonidal Excision, Pilonidal recurrence