Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439291
• Other study ID #: IRB-65058
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: January 2027

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Bill Chiu, MD
• Phone: 650-723-6439
• Email: bchiu[@]stanfordchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

Procedure:
• Regular Epilation Regimen
Epilation using laser device
• Surgical excision
Excision of pilonidal pit with trephine

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with recurrent symptoms of pilonidal disease		Up to 1 year
Secondary	Number of participants requiring antibiotic treatment		Up to 1 year
Secondary	Time taken off from school or work due to pilonidal disease		Up to 1 year
Secondary	Effect on parent's daily activities	Parents measure the effect of caring for afflicted children on a 0-10 rating scale, higher scores correspond to more difficulties.	Baseline to 1 year
Secondary	Number of participants requiring additional surgical intervention		Up to 1 year