Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2027-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pilonidal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Regular epilation regimen only

Group Type ACTIVE_COMPARATOR

Regular Epilation Regimen

Intervention Type PROCEDURE

Epilation using laser device

Regular epilation regimen with surgical excision

Group Type ACTIVE_COMPARATOR

Regular Epilation Regimen

Intervention Type PROCEDURE

Epilation using laser device

Surgical excision

Intervention Type PROCEDURE

Excision of pilonidal pit with trephine

Interventions

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Regular Epilation Regimen

Epilation using laser device

Intervention Type PROCEDURE

Surgical excision

Excision of pilonidal pit with trephine

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No