Pilonidal DiseaseNCT05439291
Comparing Operative vs Non Operative Treatment for Pilonidal Disease
A study testing Regular Epilation Regimen and Surgical excision in people with Pilonidal Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Regular Epilation Regimen and Surgical excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at Stanford Healthcare with pilonidal disease.
- Patients over the age of 8yrs.
Who cannot join
- Inability to read, write or understand English ***or Spanish
- Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94304
Bill Chiu, 650-723-6439, bchiu@stanfordchildrens.org
About this study
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.
Read the 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
- Being tested
- Regular Epilation Regimen, Surgical excision
- Keywords
- Pilonidal Surgery, Pilonidal Excision, Pilonidal recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Epilation RegimenProcedure or surgery
Epilation using laser device
Surgical excisionProcedure or surgery
Excision of pilonidal pit with trephine
| Study group | Role | What they receive |
|---|---|---|
| Regular epilation regimen only | Active comparator | Not described Receives: Procedure: Regular Epilation Regimen |
| Regular epilation regimen with surgical excision | Active comparator | Not described Receives: Procedure: Regular Epilation Regimen; Procedure: Surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrent symptoms of pilonidal disease
Measured: Up to 1 year
Secondary outcomes (4)
Number of participants requiring antibiotic treatment
Measured: Up to 1 year
Time taken off from school or work due to pilonidal disease
Measured: 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.
Measured: Baseline to 1 year
Number of participants requiring additional surgical intervention
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start19 Jul 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bill Chiu, MD, Stanford University
- Investigators
- Bill Chiu, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439291
- Sponsor's protocol ID
- IRB-65058
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Operative vs Non Operative Treatment for Pilonidal Disease
- ClinicalTrials.gov ID
- NCT05439291
- Acronym / sponsor ID
- IRB-65058
- Conditions
- Pilonidal Disease
- Keywords
- Pilonidal Surgery, Pilonidal Excision, Pilonidal recurrence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at Stanford Healthcare with pilonidal disease.
- Patients over the age of 8yrs.
Key exclusion criteria (2 listed)
- Inability to read, write or understand English ***or Spanish
- Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Epilation RegimenEpilation using laser device | Procedure or surgery | Regular epilation regimen only, Regular epilation regimen with surgical excision |
| Surgical excisionExcision of pilonidal pit with trephine | Procedure or surgery | Regular epilation regimen with surgical excision |
Primary outcome
Number of participants with recurrent symptoms of pilonidal disease
Time frame: Up to 1 year
4 secondary outcomes
Number of participants requiring antibiotic treatment
Time frame: Up to 1 year
Time taken off from school or work due to pilonidal disease
Time frame: Up to 1 year
Effect on parent's daily activities
Time frame: Baseline to 1 year
Number of participants requiring additional surgical intervention
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bill Chiu, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Epilation Regimen and Surgical excision in people with Pilonidal Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bill Chiu, MD (650-723-6439, bchiu@stanfordchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrent symptoms of pilonidal disease (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.