Comparing surgery and hair removal for pilonidal disease treatment
Comparing Operative vs Non Operative Treatment for Pilonidal Disease
This study is testing whether people with pilonidal disease can avoid surgery by just keeping up with regular hair removal after their symptoms go away.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 8 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05439291 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether surgical excision is necessary for patients with pilonidal disease who follow a regular hair removal regimen, such as laser epilation, after their initial symptoms resolve. It involves a randomized controlled trial where participants will be assigned to either continue with hair removal alone or undergo surgical excision in addition to hair removal. The study aims to assess the effectiveness of these approaches in preventing recurrence of the disease, which can cause significant discomfort and social challenges for affected individuals. Patient surveys and clinical notes will be utilized to gather data on outcomes and experiences.
Who should consider this trial
Good fit: Ideal candidates are patients aged 8 years and older with pilonidal disease being treated at Stanford Healthcare.
Not a fit: Patients who cannot read, write, or understand English or Spanish, or those with intellectual disabilities that prevent comprehension of the study materials will not benefit.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with pilonidal disease, reducing the need for surgery.
How similar studies have performed: While the standard treatment involves surgical excision, this approach of comparing non-operative management with surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford University School of Medicine — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Bill Chiu, MD — Stanford University
- Study coordinator: Bill Chiu, MD
- Email: bchiu@stanfordchildrens.org
- Phone: 650-723-6439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.