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

NCT06518499 | Recruiting

• 1 other identifier: Ivstrh 172
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complication Rate

  30 days post-surgery

• Aesthetic Outcome (Visual Analog Score for pain)

  Up to 1 year post-surgery

• Healing Time

  Up to 12 weeks post-surgery

• Functional Recovery

  Up to 24 weeks post-surgery

Study Arms (3)

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

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

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

Interventions

Pilonidal sinus surgery PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female patients 18 years old and older
• Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
• No previous surgical treatment for pilonidal sinus.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Istanbul, Other, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Adnan Gundogdu

CONTACT

+905367173909; adnangundogdu89@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 24, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)