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NCT Number: NCT06518499

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.

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Istanbul, Other, Turkey (Türkiye)

Location status: Recruiting

Location contact

Adnan Gundogdu

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilonidal sinus surgery

Procedure

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

Primary outcomes

  1. Recurrence Rate

    Time frame: 12 months post-surgery

    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.

Secondary outcomes

  1. Complication Rate

    Time frame: 30 days post-surgery

    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.

  2. Aesthetic Outcome (Visual Analog Score for pain)

    Time frame: Up to 1 year post-surgery

    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.

  3. Healing Time

    Time frame: Up to 12 weeks post-surgery

    This measure records the time required for complete wound healing post-surgery, defined as the integrity along the incision line without any complications.

  4. Functional Recovery

    Time frame: Up to 24 weeks post-surgery

    This measure assesses the time taken for patients to resume daily activities comfortably.

Study contacts

Contact information is provided by the study sponsor or research team.

Adnan Gundogdu

CONTACT

[email protected]

+905367173909

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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