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临床试验/NCT01792557
NCT01792557Unknown不适用

Crystallized Phenol Application Versus Transposition Flaps for Treatment of Sacrococcygeal Pilonidal Disease: A Prospective Randomized Study

S.B. Konya Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Crystallized Phenol Group

干预措施: Crystallized phenol (Drug)

Limberg

Active Comparator

Limberg Flap Group

干预措施: Limberg Flap (Procedure)

Modified Limberg

Active Comparator

Modified Limberg Flap Group

干预措施: Modified Limberg Flap (Procedure)

Karydakis

Active Comparator

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)

研究者

发起方
S.B. Konya Education and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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