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临床试验/NCT05439291
NCT05439291招募中不适用

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Stanford University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Number of participants with recurrent symptoms of pilonidal disease

研究概览

简要总结

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

详细描述

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation. Patients with pilonidal disease can have significant pain and drainage at the gluteal cleft, and recurrent disease in this teenage and young adult population often leads to social embarrassment, isolation, and time off from work or school. Effective therapy to prevent recurrent disease is urgently needed.

The current standard of care is excision of pilonidal cyst. The research will consist of randomized 1:1 controlled trial comparing regular epilation regimen only vs. regular epilation regimen with surgical excision. The research will consist of patient surveys and clinical notes. Surgical excision is not needed to be part of this research.

All patients will receive surveys and their charts will be reviewed. At the point of treatment decision making, the patients will be randomized to one of the two options.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients at Stanford Healthcare with pilonidal disease.
  • •Patients over the age of 8yrs.

排除标准

  • •Inability to read, write or understand English ***or Spanish
  • •Intellectual disability precluding the patient from being able to comprehend or respond to the questionnaire

研究组 & 干预措施

Regular epilation regimen only

Active Comparator

干预措施: Regular Epilation Regimen (Procedure)

Regular epilation regimen with surgical excision

Active Comparator

干预措施: Regular Epilation Regimen (Procedure)

Regular epilation regimen with surgical excision

Active Comparator

干预措施: Surgical excision (Procedure)

结局指标

主要结局

Number of participants with recurrent symptoms of pilonidal disease

时间窗: Up to 1 year

次要结局

  • Number of participants requiring antibiotic treatment(Up to 1 year)
  • Time taken off from school or work due to pilonidal disease(Up to 1 year)
  • Effect on parent's daily activities(Baseline to 1 year)
  • Number of participants requiring additional surgical intervention(Up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bill Chiu, MD

Associate Professor of Surgery

Stanford University

研究点 (1)

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