Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
- Conditions
- Pilonidal Sinus
- Interventions
- Procedure: Pilonidal sinus surgery
- Registration Number
- NCT06518499
- Lead Sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 145
- Female patients 18 years old and older
- Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
- No previous surgical treatment for pilonidal sinus.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Karydakis Pilonidal sinus surgery The Karydakis primary closure procedure involves placing the patient in a prone position under spinal or general anesthesia. The surgical area around the natal cleft is shaved and cleaned thoroughly. A symmetric elliptical excision is performed 2 cm lateral to the midline, removing all affected pilonidal sinus tissue and some surrounding normal tissue. A skin flap, 2 cm wide and 1 cm thick, is mobilized from the contralateral side to cover the resultant defect. The flap is secured using a continuous suture technique, with the skin closed using polypropylene mattress sutures. A low-suction drain is used to standardize the procedure, removed when drainage decreases to less than 20 ml/day. Bascom's Pit-Pick procedure Pilonidal sinus surgery The Bascom pit-pick procedure is performed under local anesthesia with the patient in a prone position, taking approximately 15-20 minutes. Pre-operative preparation includes shaving and cleaning the surgical area. Local anesthesia (lidocaine with adrenaline) is typically used, with general anesthesia as an alternative if needed. The surgical technique involves excising midline pits with a scalpel, removing infected granulation tissue and hairs through curettage or a lateral incision. Midline wounds and nearby secondary pits are sutured with polypropylene, while the lateral incision is left open and covered with a hydrofibre bandage to heal by secondary intention. Primary Closure Pilonidal sinus surgery The primary closure technique for pilonidal sinus involves placing the patient in a prone position under spinal or general anesthesia, shaving and cleaning the surgical area, and making an elliptical incision to remove the affected tissue. A skin flap is then mobilized from the surrounding area to cover the excision site, and the wound is closed with sutures.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Functional Recovery Up to 24 weeks post-surgery This measure assesses the time taken for patients to resume daily activities comfortably.
Trial Locations
- Locations (1)
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
🇹🇷İstanbul, Other, Turkey