Comparing Operative vs Non Operative Treatment for Pilonidal Disease

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Stanford University

Status

Enrolling

Conditions

Pilonidal Disease

Treatments

Procedure: Regular Epilation Regimen
Procedure: Surgical excision

Study type

Interventional

Funder types

Other

Identifiers

NCT05439291
IRB-65058

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

8+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

Regular epilation regimen only
Active Comparator group
Treatment:
Procedure: Regular Epilation Regimen
Regular epilation regimen with surgical excision
Active Comparator group
Treatment:
Procedure: Surgical excision
Procedure: Regular Epilation Regimen

Trial contacts and locations

1

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Central trial contact

Bill Chiu, MD

Data sourced from clinicaltrials.gov

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