Pilonidal Sinus
Conditions
Brief summary
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
PROCEDUREPilonidal sinus surgery
Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure
Sponsors
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rate | 12 months post-surgery | This measure evaluates the rate of pilonidal sinus disease recurrence in female patients undergoing Karydakis flap or Bascom's pit-pick surgical procedures over a 12-month period. Recurrence is defined as the reappearance of disease symptoms after the wound has completely healed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication Rate | 30 days post-surgery | This measure records the incidence of postoperative complications such as infections (superficial or deep), seromas, hematomas, wound dehiscence (partial or complete), and anesthesia-related complications within the first 30 days post-surgery. |
| Aesthetic Outcome (Visual Analog Score for pain) | Up to 1 year post-surgery | Assessment of aesthetic outcomes using the Visual Analog Scale (VAS) for pain. The 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. |
| Healing Time | Up to 12 weeks post-surgery | This measure records the time required for complete wound healing post-surgery, defined as the integrity along the incision line without any complications. |
| Functional Recovery | Up to 24 weeks post-surgery | This measure assesses the time taken for patients to resume daily activities comfortably. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAdnan Gundogdu
Outcome results
None listed