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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Disease
• Intervention / Treatment: Procedure: Regular Epilation Regimen; Procedure: Surgical excision

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bill Chiu, MD; Phone Number: 650-723-6439; Email: bchiu@stanfordchildrens.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Bill Chiu; Phone Number: 650-723-6439; Email: bchiu@stanfordchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular epilation regimen only	Procedure: Regular Epilation Regimen; Epilation using laser device
Active Comparator: Regular epilation regimen with surgical excision	Procedure: Regular Epilation Regimen; Epilation using laser device; Procedure: Surgical excision; Excision of pilonidal pit with trephine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with recurrent symptoms of pilonidal disease	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
Number of participants requiring additional surgical intervention		Up to 1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Bill Chiu, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pilonidal Surgery; Pilonidal Excision; Pilonidal recurrence
• Other Study ID Numbers: IRB-65058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No