Comparing Operative vs Non Operative Treatment for Pilonidal Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regular Epilation Regimen, Surgical excision.
- Who it may be relevant to
- Registry conditions: Pilonidal Disease. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Regular Epilation Regimen
Epilation using laser device - Procedure Surgical excision
Excision of pilonidal pit with trephine
Primary outcome measures
- Number of participants with recurrent symptoms of pilonidal disease [Time frame: Up to 1 year]
Secondary outcome measures (4)
- Number of participants requiring antibiotic treatment [Time frame: Up to 1 year]
- Time taken off from school or work due to pilonidal disease [Time frame: Up to 1 year]
- Effect on parent's daily activities [Time frame: Baseline to 1 year]
- Number of participants requiring additional surgical intervention [Time frame: Up to 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Stanford University School of Medicine — Palo Alto
Identifiers
NCT: NCT05439291 · IRB-65058