The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
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
- 否
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
Brian Rotenberg
Assistant Professor
Western University, Canada
