Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Not Applicable

Recruiting

• Conditions: Pilonidal Disease
• Interventions: Procedure: Regular Epilation Regimen; Procedure: Surgical excision

• Registration Number: NCT05439291
• Lead Sponsor: Stanford University

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-30
• Study Start: 2022-07-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients at Stanford Healthcare with pilonidal disease.
• Patients over the age of 8yrs.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular epilation regimen with surgical excision	Regular Epilation Regimen	-
Regular epilation regimen only	Regular Epilation Regimen	-
Regular epilation regimen with surgical excision	Surgical excision	-

Primary Outcome Measures

Name	Time	Method
Number of participants with recurrent symptoms of pilonidal disease	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Number of participants requiring antibiotic treatment	Up to 1 year
Time taken off from school or work due to pilonidal disease	Up to 1 year
Effect on parent's daily activities	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.
Number of participants requiring additional surgical intervention	Up to 1 year

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States