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临床试验/NCT01793987
NCT01793987Unknown不适用

The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial

Western University, Canada2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
试验地点
2
主要终点
Blood loss

研究概览

简要总结

Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms, including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects close to 5% of the Canadian population(2). When medical therapy fails, patients are often referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management. Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed medical management(3). Traditionally, the microdebrider has been the go-to tool for performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than so-called "cold" surgical techniques (i.e. the microdebrider). In a retrospective study by Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of less intraoperative blood loss when the Coblator was used in their surgery, than those patients who underwent surgery with the microdebrider. The investigators plan to further investigate this in a randomized, controlled fashion

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18-70 years old, and
  • having a diagnosis of CRS.

排除标准

  • previous Endoscopic Sinus Surgery,
  • coagulopathies,
  • being pregnant, or
  • being prescribed anti-coagulants or anti-platelet agents

结局指标

主要结局

Blood loss

时间窗: intra-operative

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Rotenberg

Assistant Professor

Western University, Canada

研究点 (2)

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