Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population: A 10-Year Single-Center Retrospective Comparative Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Failure rate
研究概览
简要总结
Pilonidal sinus disease (PSD) in children is associated with significant morbidity and recurrence risk. Multiple surgical techniques are used, including excision with open healing, primary midline closure, off-midline closure, flap reconstruction, and minimally invasive approaches. However, high-quality comparative data in pediatric populations are limited, and adult data cannot be directly extrapolated.
This single-center retrospective cohort study aims to compare the effectiveness of different surgical techniques used for curative treatment of PSD in children treated at CHU Angers between January 1, 2015 and March 31, 2025.
The primary endpoint is surgical failure at 2 months, defined as absence of complete wound healing or early recurrence. Secondary outcomes include postoperative complications, time to healing, pain outcomes, length of hospital stay, and recurrence at 1 year.
Results are expected to help optimize institutional management strategies and contribute to pediatric-specific evidence.
详细描述
This is a single-center retrospective observational cohort study conducted in the Departments of Pediatric Surgery and Visceral Surgery at CHU Angers, France.
All consecutive patients under 18 years of age who underwent surgical treatment for pilonidal sinus disease between January 1, 2015 and March 31, 2025 will be included.
Surgical techniques analyzed include:
- Wide excision with open healing
- Wide excision with primary midline closure
- Wide excision with primary midline closure and negative pressure wound therapy
- Minimally invasive/endoscopic techniques The primary objective is to compare treatment effectiveness at 2 months postoperatively. Secondary objectives include comparison of complication rates, healing delay, postoperative pain, and recurrence at 1 year, as well as identification of predictive factors for recurrence.
Data will be extracted from medical records and anonymized prior to statistical analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years at time of surgery
- •Surgical treatment for pilonidal sinus disease
- •Surgery performed between January 1, 2015 and March 31, 2025
- •Managed at CHU Angers (Pediatric or Visceral Surgery departments)
- •ICD-10 diagnosis code L05.9
- •CCAM procedure code QBFA007
排除标准
- •Emergency incision and drainage of acute pilonidal abscess (CCAM QBPA001)
- •Initial surgical management performed at another institution
- •Refusal of participation (patient and/or legal guardians, if applicable)
- •Alternative diagnosis (anal abscess, gluteal abscess)
研究组 & 干预措施
Wide excision with open healing
Intentional traditional treatment whitch consists in wide excision of the pilonidal sinus, and progressive healing of the wound thanks to daily dressing changes until complete closure is obtained.
干预措施: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. (Procedure)
Wide excision with primary midline closure
Alternative technique using an immediate closure of the wound with layer of stiches, and regular dressings
干预措施: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. (Procedure)
Wide excision with primary midline closure and negative pressure wound therapy
Alternative technique using an immediate closure of the wound with layer of stiches, completed with negative pressure therapy dressing, allowing for a fater recovery while requiring less dressing survey and changes.
干预措施: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. (Procedure)
Minimally invasive/endoscopic techniques
Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques.
干预措施: Surgical treatment for pilonidal sinus disease, including various techniques including excision with or without primary closure, or endoscopic techniques. (Procedure)
结局指标
主要结局
Failure rate
时间窗: 2 months after surgery
Definition of failure: * Absence of complete wound healing at 2 months, OR * Clinical recurrence of pilonidal sinus within 2 months
次要结局
- Analgesic consumption for postoperative pain(Up to 30 days)
- Length of hospital stay(at hospital discharge)
- Postoperative complications(Up to 1 year)
- Time to complete wound healing(Up to 1 year)
- Postoperative pain duration(Up to 30 days)
- Postoperative pain Intensity(Up to 30 days)
- Predictive factors for recurrence(Up to last follow-up)
- Recurrence rate(Up to 1 year)