Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having two pits or less

Disqualifiers

With bilateral lateral extension,

Stage-R with recurrent disease

Number of pits more than three pits,

Collagen tissue disease,

Trial population

Female patients aged 18 and older with pilonidal sinus disease and two or fewer pits, with no previous surgical treatment.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

165 Participants
are grouped into 3 trial groups
Group A: Bascom's pit-picking
Group B: Crystallized phenol
Group C: Combined treatment

Trial outcomes

Primary outcomes

1

Treatment Success

The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing.

Time frame
Up to 12 months post-treatment
2

Postoperative Complications

This measure will assess the incidence of postoperative complications such as infection and pain.

Time frame
Up to 3 months post-treatment.

Secondary outcomes

1

Recurrence Rate

Evaluation of the rate of disease recurrence after treatment.

Time frame
Up to 12 months post-treatment
2

Chronic Pain Level

Assessment of chronic pain levels in patients following treatment using the Visual Analog Scale (VAS). VAS is a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.

Time frame
Up to 3 months post-treatment
3

Patient Satisfaction

Measurement of patient satisfaction with the treatment process and outcomes using the Patient and Observer Scar Assessment Scale (POSAS). POSAS is a scale from 1 to 10, where 1 represents the best outcome and 10 represents the worst outcome. Higher scores indicate worse outcomes.

Time frame
Up to 12 months post-treatment

Other outcomes

Sponsors and contacts

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