Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women

NCT ID: NCT06518499

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-08-20

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).

Conditions

Pilonidal Sinus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Bascom's Pit-Pick procedure

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.

Pilonidal sinus surgery

Intervention Type: PROCEDURE

Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure

Primary Closure

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.

Pilonidal sinus surgery

Intervention Type: PROCEDURE

Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure

Karydakis

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.

Pilonidal sinus surgery

Intervention Type: PROCEDURE

Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure

Interventions

Pilonidal sinus surgery

Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital

Istanbul, Other, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Adnan Gundogdu

Role: CONTACT

adnangundogdu89@gmail.com

+905367173909

Facility Contacts

Adnan Gundogdu

Role: primary

Other Identifiers

Ivstrh 172

Identifier Type: -

Identifier Source: org_study_id