Comparing Operative vs Non Operative Treatment for Pilonidal Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pilonidal Disease
- Sponsor
- Stanford University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Number of participants with recurrent symptoms of pilonidal disease
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Bill Chiu, MD
Associate Professor of Surgery
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with recurrent symptoms of pilonidal disease
Time Frame: Up to 1 year
Secondary Outcomes
- 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(Baseline to 1 year)
- Number of participants requiring additional surgical intervention(Up to 1 year)