Comparing Operative vs Non Operative Treatment for Pilonidal Disease
ConditionPilonidal Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients at Stanford Healthcare with pilonidal disease.
Patients over the age of 8yrs.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Regular Epilation Regimen
Procedure/SurgeryEpilation using laser device
Surgical excision
Procedure/SurgeryExcision of pilonidal pit with trephine
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Regular epilation regimen onlyActive comparator 1 intervention
Group B: Regular epilation regimen with surgical excisionActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with recurrent symptoms of pilonidal disease
Time frame
Up to 1 yearSecondary outcomes
1
Number of participants requiring antibiotic treatment
Time frame
Up to 1 year2
Time taken off from school or work due to pilonidal disease
Time frame
Up to 1 year3
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.
Time frame
Baseline to 1 year4
Number of participants requiring additional surgical intervention
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov