Evaluation of Thermal Spread Into the Interstitial Portion of the Fallopian Tubes Using the Ligasure Device at Time of Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.
研究概览
简要总结
Some patients, specifically those with a diagnosed genetic mutation, will have their ovaries and fallopian tubes removed without removal of the uterus in an attempt to prevent ovarian and fallopian tube cancer from developing.
Anatomically the fallopian tubes are attached to the uterus and extend towards the ovaries. The fallopian tube tissue arises within the corner area of the uterus and occupies about 1cm of the uterine muscle wall.
The purpose of this study is to determine if the technique used to remove fallopian tubes only (without removal of the uterus) adequately removes or destroys all the fallopian tube cells that remain in the uterine muscle wall.
Currently, during the operation an instrument is used that burns the fallopian tube and allows it to be cut away from the uterus. The investigators do not know if this procedure successfully destroys all the fallopian tube cells within the uterus. Therefore, we will compare this single step procedure to a two step procedure. The two step procedure is to burn and cut the fallopian tube followed by an additional burning step, called cauterization at the top of the uterus. The investigators will assess if either or both of these procedures destroy the fallopian tube cells that may remain inside the uterine wall. This is important to determine since the goal is to remove the ovaries and all of the fallopian tubes in order to prevent future development of ovarian or fallopian tube cancer.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing a non-emergent total hysterectomy with removal of the tubes and ovaries by the gynecologic service for benign or malignant conditions uterine, cervical or early ovarian cancer.
- •Patients will undergo either a laparotomy, total laparoscopy or laparoscopically assisted vaginal hysterectomy
- •Patients will be 21 years and older.
排除标准
- •Patients with abnormal fallopian tubes seen preoperatively by radiologic exam or intraoperatively by visual inspection.
- •Patients who are suspected to have fallopian tube cancer prior to their surgery
- •Patients who have had prior pelvic radiation therapy
- •Patients who are undergoing a Robotically Assisted procedure
- •Patients who have had any type of prior tubal surgery
研究组 & 干预措施
1
The patients will already be undergoing a total hysterectomy with removal of the tubes and ovaries for a specific indication diagnosed or defined by their surgeon. If the patient is suitable to proceed by the surgeon, then he/she will perform a right salpingooophorectomy with the LigaSure devices.
干预措施: LigaSure vessel sealing system (Device)
结局指标
主要结局
To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.
时间窗: conclusion of the study
次要结局
未报告次要终点