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NCT Number: NCT05439291

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

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.

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Key information

Conditions

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Bill Chiu

CONTACT

[email protected]

650-723-6439

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regular Epilation Regimen

Procedure

Epilation using laser device

Surgical excision

Procedure

Excision of pilonidal pit with trephine

Primary outcomes

  1. Number of participants with recurrent symptoms of pilonidal disease

    Time frame: Up to 1 year

Secondary outcomes

  1. Number of participants requiring antibiotic treatment

    Time frame: Up to 1 year

  2. Time taken off from school or work due to pilonidal disease

    Time frame: Up to 1 year

  3. Effect on parent's daily activities

    Time frame: Baseline to 1 year

    Parents measure the effect of caring for afflicted children on a 0-10 rating scale, higher scores correspond to more difficulties.

  4. Number of participants requiring additional surgical intervention

    Time frame: Up to 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Bill Chiu, MD

CONTACT

[email protected]

650-723-6439

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2022
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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