Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assessment of recurrence
研究概览
简要总结
Although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
详细描述
Pilonidal sinus disease (PSD) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. Its incidence is reported 26 per 100000 in a Norwegian study. Although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. Surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. We would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. We believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Patients with pilonidal disease
排除标准
- •Previous history of pilonidal disease treatment
- •Pregnant or breast-feeding women
- •Systemic diseases that would affect wound healing
- •Chronic renal failure
- •Autoimmune diseases
- •Malignant diseases
研究组 & 干预措施
Phenol
Crystallized Phenol Group
干预措施: Crystallized phenol (Drug)
Limberg
Limberg Flap Group
干预措施: Limberg Flap (Procedure)
Modified Limberg
Modified Limberg Flap Group
干预措施: Modified Limberg Flap (Procedure)
Karydakis
Karydakis Flap Group
干预措施: Karydakis Flap (Procedure)
结局指标
主要结局
Assessment of recurrence
时间窗: 3rd year
Patients will be followed up for recurrence for three years. Total recurrence will be evaluated at the end of 3rd year.
次要结局
- Assessment of patient comfort(1st year)
- Assessment of recovery duration(3rd month)
- Assessment of complications(3rd month)
