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Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05439291
Enrollment
400
Registered
2022-06-30
Start date
2022-07-19
Completion date
2027-01-31
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal Disease

Keywords

Pilonidal Surgery, Pilonidal Excision, Pilonidal recurrence

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.

Interventions

PROCEDURERegular Epilation Regimen

Epilation using laser device

Excision of pilonidal pit with trephine

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with recurrent symptoms of pilonidal diseaseUp to 1 year

Secondary

MeasureTime frameDescription
Number of participants requiring antibiotic treatmentUp to 1 year
Time taken off from school or work due to pilonidal diseaseUp to 1 year
Effect on parent's daily activitiesBaseline to 1 yearParents measure the effect of caring for afflicted children on a 0-10 rating scale, higher scores correspond to more difficulties.
Number of participants requiring additional surgical interventionUp to 1 year

Countries

United States

Contacts

Primary ContactBill Chiu, MD
bchiu@stanfordchildrens.org650-723-6439

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026