Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
研究概览
地位
详细说明
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Bayern
-
Munich、Bayern、德国、81675
- Department of Ear Nose Throat
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally
Exclusion Criteria:
- Prior radiotherapy or chemotherapy
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients with benign or malign tumor in the oropharynx
Patient of 18 years and older with benign or malign tumor in the oropharynx.
The resection is done transorally by radiofrequency
|
Patient of 18 years and older with benign or malign tumor in the oropharynx.
The resection is done transorally by radiofrequency
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
total blood loss,
大体时间:intraoperative
|
assessing the blood loss by measuring blood in the suction
|
intraoperative
|
|
tissuesticking
大体时间:intraoperative
|
tissuesticking by physician global assessment scale from 1 - 6
|
intraoperative
|
|
coagulation
大体时间:intraoperative
|
coagulation by physician global assessment scale from 1 - 6,
|
intraoperative
|
|
Duration of Operation
大体时间:intraoperative
|
measuring Duration of Operation in minutes
|
intraoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Zone of coagulation
大体时间:within one month after the operation
|
Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,
|
within one month after the operation
|
|
postoperative parameters
大体时间:within one month after the operations
|
woundhealing by Parameters normal, delayed, infection;
|
within one month after the operations
|
|
postoperative pain
大体时间:within one month after the operations
|
postoperative pain by visual analog scale from 0 -10,
|
within one month after the operations
|
|
accuracy of section
大体时间:within one month after the operations
|
accuracy of section assessed by a scale from 1 - 6
|
within one month after the operations
|
|
status of resection
大体时间:within one month after the operations
|
assessment of status of resection by assessing the margins of resection for Tumor scale from 1 - 6,
|
within one month after the operations
|
|
postoperative dysfunctions by descriptive name of scale
大体时间:within one month after the operations
|
postoperative dysfunctions by descriptive scale from 1 -10
|
within one month after the operations
|
合作者和调查者
调查人员
- 首席研究员:Clemens Heiser, MD、department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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