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临床试验/NCT02017834
NCT02017834已完成不适用

Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.

University of Calgary2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
blood loss

研究概览

简要总结

The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years
  • oral cavity scc
  • primary surgery including either uni or bilateral neck dissection (levels I-IV)

排除标准

  • previous treatment for head and neck cancer
  • unable or unwilling to give informed consent
  • history of bleeding disorder
  • other contraindications to surgery

结局指标

主要结局

blood loss

时间窗: intraoperative

次要结局

  • operating time(intraoperative)

研究者

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

Joseph C. Dort

Ohlson Professor of Head & Neck Surgery

University of Calgary

研究点 (2)

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