An observational study in Pilonidal Sinus, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
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.
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).
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 145 is close to the median of 145 across 37 observational studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients aged 18 and older with pilonidal sinus disease and three or fewer pits, with no previous surgical treatment.
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Exclusion Criteria:
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.
Procedure: 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.
Procedure: 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.
Procedure: Pilonidal sinus surgery
Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure
Recurrence Rate
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.
Time frame: 12 months post-surgery
Complication Rate
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.
Time frame: 30 days post-surgery
Aesthetic Outcome (Visual Analog Score for pain)
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.
Time frame: Up to 1 year post-surgery
Healing Time
This measure records the time required for complete wound healing post-surgery, defined as the integrity along the incision line without any complications.
Time frame: Up to 12 weeks post-surgery
Functional Recovery
This measure assesses the time taken for patients to resume daily activities comfortably.
Time frame: Up to 24 weeks post-surgery
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Jul 2026, 24 months after the start.
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital