Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Distance from the ureter to the uterine vessels
研究概览
简要总结
The purpose of this study is to improve the safety of surgery to remove a uterus (a hysterectomy) by better understanding where a patient's ureters lie.
详细描述
Objectives:
Primary: (While uterus is under tension)
- To determine the shortest distance from the ureter to the uterine vessels.
- To determine the distances from the ureter to the gonadal vessels in infundibulo-pelvic (IP) at the pelvic sidewall. This will be defined at the distance from the IP ligament at the level of the pelvic sidewall to the point on the ureter directly below these vessels
- To determine the distances from the ureter to the gonadal vessels in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This will be defined as the distance from where the vessels in the IP enter the ovary to the point on the ureter directly below this.
Secondary
- To determine thermal spread from the Ligasure, and Harmonic device using H&E and Movat staining.
- To determine the burst pressure of segments of IP ligament that have undergone Ligasure or Harmonic electrosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing minimally invasive surgery (MIS) hysterectomy with Bilateral Salpingo Oophorectomy (BSO) for either a benign or malignant condition.
- •Performance Status of 0-1
- •Must have the ability to understand and willingness to sign a written informed consent document
排除标准
- •History of radical pelvic surgery.
- •History of stage IV-V uterine prolapse or hysteropexy
- •History of prior ureteral injury or retroperitoneal dissection
- •Known hydronephrosis.
- •Known congenital genitourinary or gynaecologic anomaly
- •Any known obstructing mass along any portion of the pelvic ureter
- •Known American Society for Reproductive Medicine (ASRM) stage III/IV endometriosis (obliteration of the cul-de-sac)
研究组 & 干预措施
Cook Bush DL™ Ureteral Illuminating Catheter
As part of this study an additional tool will be used during the hysterectomy. This tool is called a Cook Bush DL™ Ureteral Illuminating Catheter, which is a lighted ureteral stent. This is a very thin tube that goes into the ureter. A urologist, who is an expert at placing these devices, will insert a stent into each ureter during surgery. The lighted stents will help effectively find the ureters and keep track of them during the surgery. This same procedure is already being done in many other forms of abdominal surgery to help find the ureter. The stents will be removed before the surgery is complete and treatment will not differ in any other way.
干预措施: Ureteral Illuminating Catheter (Device)
结局指标
主要结局
Distance from the ureter to the uterine vessels
时间窗: Cross-sectional measurement at time of surgery
To determine the shortest distance from the ureter to the uterine vessels to show the variation of ureteral position to the uterine and gonadal vessels during total laparoscopic hysterectomy prior to and following opening the retroperitoneum. Lighted ureteral stents will be placed cystoscopically. This will be done to clearly delineate the ureter and facilitate measuring the ureter to the infundibulopelvic (IP) and ureter to uterine vessel distances.
The distance from the ureter to the right gonadal vessel at the pelvic sidewall
时间窗: Cross-sectional measurement at time of surgery
To determine the average distance from the ureter to the right gonadal vessel in infundibulo-pelvic (IP) at the pelvic sidewall. This is to show the variation of ureteral position to the uterine and gonadal vessels during total laparoscopic hysterectomy prior to and following opening the retroperitoneum. Lighted ureteral stents will be placed cystoscopically. This will be done to clearly delineate the ureter and facilitate measuring the ureter to the infundibulopelvic (IP) and ureter to uterine vessel distances.
The distance from the ureter to the left gonadal vessel at the pelvic sidewall
时间窗: Cross-sectional measurement at time of surgery
To determine the distance from the ureter to the left gonadal vessel in infundibulo-pelvic (IP) at the pelvic sidewall. This is to show the variation of ureteral position to the uterine and gonadal vessels during total laparoscopic hysterectomy prior to and following opening the retroperitoneum. Lighted ureteral stents will be placed cystoscopically. This will be done to clearly delineate the ureter and facilitate measuring the ureter to the infundibulopelvic (IP) and ureter to uterine vessel distances.
The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary
时间窗: Cross-sectional measurement at time of surgery
To determine the distance from the ureter to the right gonadal vessel in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This is to show the variation of ureteral position to the uterine and gonadal vessels during total laparoscopic hysterectomy prior to and following opening the retroperitoneum. Lighted ureteral stents will be placed cystoscopically. This will be done to clearly delineate the ureter and facilitate measuring the ureter to the infundibulopelvic (IP) and ureter to uterine vessel distances.
The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary
时间窗: Cross-sectional measurement at time of surgery
To determine the distance from the ureter to the left gonadal vessel in the infundibulo-pelvic (IP) ligament at the point where the gonadal vessels enter in to the ovary. This is to show the variation of ureteral position to the uterine and gonadal vessels during total laparoscopic hysterectomy prior to and following opening the retroperitoneum. Lighted ureteral stents will be placed cystoscopically. This will be done to clearly delineate the ureter and facilitate measuring the ureter to the infundibulopelvic (IP) and ureter to uterine vessel distances.
次要结局
- To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery(Cross-sectional measurement at time of surgery)
- To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery(Cross-sectional measurement at time of surgery)