Comparing Operative vs Non Operative Treatment for Pilonidal Disease

NCT05439291 | Recruiting

• 1 other identifier: IRB-65058
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Keywords

Pilonidal Surgery; Pilonidal Excision; Pilonidal recurrence

Outcome Measures

Primary Outcomes (1)

• Number of participants with recurrent symptoms of pilonidal disease

  Up to 1 year

Secondary Outcomes (4)

• 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

• Number of participants requiring additional surgical intervention

  Up to 1 year

Study Arms (2)

Regular epilation regimen only

ACTIVE COMPARATOR

Procedure: Regular Epilation Regimen

Regular epilation regimen with surgical excision

ACTIVE COMPARATOR

Procedure: Regular Epilation Regimen; Procedure: Surgical excision

Interventions

Regular Epilation Regimen PROCEDURE

Epilation using laser device

Regular epilation regimen only; Regular epilation regimen with surgical excision

Surgical excision PROCEDURE

Excision of pilonidal pit with trephine

Regular epilation regimen with surgical excision

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to read, write or understand English \*\*\*or Spanish
• Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Study Officials

• Bill Chiu, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bill Chiu, MD

CONTACT

650-723-6439; bchiu@stanfordchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

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

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 30, 2022
• Study Start: July 19, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)