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临床试验/NCT06517472
NCT06517472招募中不适用

Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
165
试验地点
1
主要终点
Postoperative Complications

研究概览

简要总结

Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

详细描述

Pilonidal sinus disease (PSD) is common, affecting approximately 26 in 100,000 people. Treatment options and outcomes vary significantly. Chronic symptomatic pilonidal sinus disease primarily affects young adults and leads to substantial work loss. Due to the heterogeneous nature of clinical presentations, finding a single treatment approach for PSD has proven difficult. Future clinical studies might benefit from focusing on the best management strategies rather than the best technique.

Literature indicates that the minimally invasive pit-picking procedure has a general treatment success rate of 68%, with low postoperative complication rates, chronic pain, and high patient satisfaction regarding cosmetic appearance. It is seen as a better option in terms of pain, wound healing time, and complication rates. For simple, uncomplicated pilonidal sinus cases, the pit-picking method is an alternative to flap surgery in terms of wound healing and recurrence.

Particularly for patients with fewer than two pits and no lateral extensions, crystallized phenol application (CPT) is a good alternative to modified Limberg flap surgery and other surgical procedures. CPT, being a minimally invasive procedure performed under local anesthesia, has higher success rates after recurrent applications and shorter hospital stays. Long-term results for CPT treatment are also quite successful. Studies show that in addition to endoscopic pilonidal sinus treatment, crystallized phenol treatment is safe, well-tolerated, and provides quick and lasting recovery without recurrence over the follow-up period.

The presented study aims to compare the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, CPT Application, and Combined Pit Picking and CPT Application. The study will evaluate the short- and long-term results, treatment success, incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the study will examine the effects of these methods on hospital stay, wound healing time, and workforce loss. The presented study aims to determine whether minimally invasive procedures and CPT treatment offer better management strategies for pilonidal sinus disease. The findings are expected to contribute to identifying the most suitable treatment method for pilonidal sinus disease.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having two pits or less

排除标准

  • With bilateral lateral extension,
  • Stage-R with recurrent disease
  • Number of pits more than three pits,
  • Collagen tissue disease,
  • Patients with a postoperative follow-up period of less than 12 months

结局指标

主要结局

Postoperative Complications

时间窗: Up to 3 months post-treatment.

This measure will assess the incidence of postoperative complications such as infection and pain.

Treatment Success

时间窗: Up to 12 months post-treatment

The primary outcome measure will evaluate the effectiveness of three different treatment methods for pilonidal sinus disease: Pit Picking, Crystallized Phenol (CPT) Application, and Combined Pit Picking and CPT Application. Effectiveness will be determined by the absence of disease recurrence and complete healing.

次要结局

  • Chronic Pain Level(Up to 3 months post-treatment)
  • Patient Satisfaction(Up to 12 months post-treatment)
  • Recurrence Rate(Up to 12 months post-treatment)

研究者

发起方
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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