NCT05439291

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pilonidal Disease

Interventions

Type	Name	Description
PROCEDURE	Regular Epilation Regimen	Epilation using laser device
PROCEDURE	Surgical excision	Excision of pilonidal pit with trephine

Timeline

• Start date: 2022-07-19
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-06-30
• Last updated: 2024-11-22

Locations

1 site across 1 country: United States