Recruiting

Operative vs. Non Operative

Sponsor:

Stanford University

Code:

NCT05439291

Conditions

Pilonidal Disease

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Regular Epilation Regimen

Surgical excision

Study Details

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

Study ID

NCT05439291

Start date

Jul 19, 2022

Status verified date

Nov, 2024

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Regular epilation regimen only

active comparator: Regular epilation regimen with surgical excision

Interventions

Regular Epilation Regimen

Epilation using laser device

Surgical excision

Excision of pilonidal pit with trephine

Primary outcome measure

  • Number of participants with recurrent symptoms of pilonidal disease [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Bill Chiu, MD

650-723-6439bchiu@stanfordchildrens.org

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Bill Chiu

650-723-6439bchiu@stanfordchildrens.org

More Information

Sponsor

Stanford University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • Pilonidal Surgery
  • Pilonidal Excision
  • Pilonidal recurrence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-22.