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临床试验/NCT02548338
NCT02548338已完成2 期

Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

Federal University of São Paulo0 个研究点目标入组 60 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
主要终点
intra-operative outcomes

研究概览

简要总结

The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical treatment using regular electric scalpel ; 2) surgical treatment using argon plasma coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a doctor using our standard clinical record and it will be measured using reliable parameters, for exemple: if the investigators clinically detect a hematoma then we'll perform an ultrasound to take the real extension; if the investigators clinically pick an infection we'll measure the extension of the hiperemia; and if the investigators clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure (centimeters) the terminal damage caused on the surgical specimens (samples) using the microscope.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • operable breast cancer

排除标准

  • coagulation disturbs

结局指标

主要结局

intra-operative outcomes

时间窗: surgery duration

evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure.

post operative outcomes

时间窗: 30 days

evaluate the occurrence of hematomas, seromas and infection using our clinical record as standard evaluation and measure it when it's possible ( like explained on the brief comments.

次要结局

  • margin damage(during the surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Hernandes Giordano

Doctor

Federal University of São Paulo

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