Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pilonidal sinus surgery.
- Who it may be relevant to
- Registry conditions: Pilonidal Sinus. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.
Detailed description
This study is a single-center, prospective observational trial aimed at comparing the effectiveness of the Karydakis flap and Bascom's pit-pick methods in treating pilonidal sinus disease in women. Female patients aged 18 and over, with three or fewer pits, will be included, and each patient will be followed for 12 months. The Bascom pit-pick method will be performed under local anesthesia, while the Karydakis method will be performed under spinal or general anesthesia. Postoperative recovery time, complications, recurrence rates, and patient satisfaction will be evaluated. Ethics committee approval has been obtained (Approval No: TE 172, Date: June 12, 2024).
Interventions
- Procedure Pilonidal sinus surgery
Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure
Primary outcome measures
- Recurrence Rate [Time frame: 12 months post-surgery]
Secondary outcome measures (4)
- Complication Rate [Time frame: 30 days post-surgery]
- Aesthetic Outcome (Visual Analog Score for pain) [Time frame: Up to 1 year post-surgery]
- Healing Time [Time frame: Up to 12 weeks post-surgery]
- Functional Recovery [Time frame: Up to 24 weeks post-surgery]
Eligibility criteria
Inclusion criteria
- Female patients 18 years old and older
- Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
- No previous surgical treatment for pilonidal sinus.
Exclusion criteria
- Under 18 years of age
- Pregnancy
- Presented with acute abscesses
- Patients with recurrent disease, Stage-R.
- >3 pit
- Collagen tissue disease
- Exceed to navicular area
- Lateral extension in both directions
- Accidentally discovered (asymptomatic) sinus or with follow-up <12 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Turkey (Türkiye) · 1 center
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital — Istanbul
Identifiers
NCT: NCT06518499 · Ivstrh 172