Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Recurrence Rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years old and older
- •Diagnosed with pilonidal sinus disease, having 3 or fewer pits.
- •No previous surgical treatment for pilonidal sinus.
排除标准
- •Under 18 years of age
- •Pregnancy
- •Presented with acute abscesses
- •Patients with recurrent disease, Stage-R.
- •Collagen tissue disease
- •Exceed to navicular area
- •Lateral extension in both directions
- •Accidentally discovered (asymptomatic) sinus or with follow-up <12 months
结局指标
主要结局
Recurrence Rate
时间窗: 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.
次要结局
- Healing Time(Up to 12 weeks post-surgery)
- Aesthetic Outcome (Visual Analog Score for pain)(Up to 1 year post-surgery)
- Complication Rate(30 days post-surgery)
- Functional Recovery(Up to 24 weeks post-surgery)