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临床试验/NCT01894971
NCT01894971已完成3 期

The Effect of Thermal Damage of Ligasure® to Destroy Cornual Portion of Fallopian Tube Tissue

Samsung Medical Center2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Remnant fallopian tube tissue after coagulation wiht Ligasure®

研究概览

简要总结

Single-center prospective randomized trial to evaluate the effect of thermal damage of Ligasure® to destroy cornual portion of fallopian tube tisse.

Right of Left side of fallpian tube is randomized and coagulated one more time than other side before cut off. The pathologist evaluate the amount of fallopian tube tissue left at both cornual portion of cut off specimen.

详细描述

When investigators perform salpingectomy, both side of cornual portion of the uterus are coagulated by Ligasure®. The randomized, the same word selected side of the fallopian tube is coagulated one more time at the cornual portion than unselected other side of fallopian tube. Hypothesis is that the side selected and coagulated twice would have less fallopian tube tisse left at fianl pathology than the side only once coagulated by Ligasure®.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female 35-50
  • premenopausal
  • plan to perform hysterectomy

排除标准

  • disease in fallopian tube before surgery
  • has history of pelvic inflammatory disease

研究组 & 干预措施

twice coagulated side of fallopian tube

Experimental

twice coagulated side of fallopian tube once coagulated sied of fallopian tube

干预措施: The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube (Device)

结局指标

主要结局

Remnant fallopian tube tissue after coagulation wiht Ligasure®

时间窗: 1 day

次要结局

未报告次要终点

研究者

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

Tae-Joong Kim

Assistant Professor

Samsung Medical Center

研究点 (2)

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