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

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.

Study Overview

• Status: Recruiting
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Pilonidal sinus surgery

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).

• Study Type: Observational
• Enrollment (Estimated): 145

Contacts and Locations

• Study Contact: Name: Adnan Gundogdu; Phone Number: +905367173909; Email: adnangundogdu89@gmail.com

Study Locations

• Turkey
  • Other
    • İstanbul, Other, Turkey
      • Recruiting
      • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
      • Contact: Adnan Gundogdu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients aged 18 and older with pilonidal sinus disease and three or fewer pits, with no previous surgical treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Pilonidal sinus surgery; 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.	Procedure: Pilonidal sinus surgery; 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.	Procedure: Pilonidal sinus surgery; Bascom's Pit-Pick procedure, Primary Closure, Karydakis procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Up to 12 weeks post-surgery
Functional Recovery	This measure assesses the time taken for patients to resume daily activities comfortably.	Up to 24 weeks post-surgery

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: Ivstrh 172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No