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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients 18 years old and older

Diagnosed with pilonidal sinus disease, having 3 or fewer pits.

No previous surgical treatment for pilonidal sinus.

Disqualifiers

Under 18 years of age

Pregnancy

Presented with acute abscesses

Patients with recurrent disease, Stage-R.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Pilonidal sinus surgery

    Procedure/Surgery

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

Treatment groups

145 Participants
are divided into 3 treatment groups
Group A: Bascom's Pit-Pick procedure1 intervention
Group B: Primary Closure1 intervention
Group C: Karydakis1 intervention

Trial outcomes

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.

Time frame
12 months post-surgery

Secondary outcomes

1

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.

Time frame
30 days post-surgery
2

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.

Time frame
Up to 1 year post-surgery
3

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.

Time frame
Up to 12 weeks post-surgery
4

Functional Recovery

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

Time frame
Up to 24 weeks post-surgery

Other outcomes

Sponsors and contacts

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