Actively Recruiting

Age: 18Years +
FEMALE
ID06518499

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

Led by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Updated on 2024-10-08

145

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating surgical treatments for pilonidal sinus disease in women, focusing on comparing the Karydakis flap method and Bascom's pit-pick procedure. The study aims to assess differences in recurrence, complications, and aesthetic outcomes, especially in female patients with three or fewer pits. This is a single-center, prospective observational trial following each patient for 12 months after surgery. The Bascom pit-pick procedure is a minimally invasive surgery performed under local anesthesia, involving the removal of affected pits and infected tissue with suturing of midline wounds and secondary pits, while some incisions heal naturally. The Karydakis procedure and primary closure involve more extensive surgical excision and flap creation under spinal or general anesthesia, with specific techniques to close the wound and use of drains for recovery. Participants will be monitored for recurrence at 12 months, with additional assessments of complication rates at 30 days, healing time up to 12 weeks, functional recovery up to 24 weeks, and aesthetic outcomes using a pain visual analog score over one year. The study includes preoperative preparation, postoperative follow-ups, and evaluation of patient satisfaction and recovery progress under ethical committee approval.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients 18 years old and older
  • Diagnosed with pilonidal sinus disease, having 3 or fewer pits
  • No previous surgical treatment for pilonidal sinus
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnancy
  • Presented with acute abscesses
  • Patients with recurrent disease, Stage-R
  • More than 3 pits
  • Collagen tissue disease
  • Disease extending beyond navicular area
  • Lateral extension in both directions
  • Accidentally discovered (asymptomatic) sinus or with follow-up less than 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo one of three surgical procedures to treat pilonidal sinus disease, performed under local, spinal, or general anesthesia. Immediate recovery is monitored following surgery.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 24 weeks post-surgery

Participants are followed to monitor healing, complications, and functional recovery after surgery.

Approximately 6 post-operative visits

Long-term Monitoring

Duration - Up to 12 months post-surgery

Participants are monitored for recurrence of pilonidal sinus and aesthetic outcomes for up to 12 months after surgery.

Periodic follow-up visits

Trial Site Locations

Total: 1 location

1

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

Istanbul, Other, Turkey (Türkiye)

Actively Recruiting

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Research Team

A

Adnan Gundogdu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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