NCT03123315

Optimization of Ureterolysis During Hysterectomy

Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hysterectomy

Interventions

Type	Name	Description
DEVICE	Ureteral Illuminating Catheter	This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2017-04-21
• Last updated: 2018-02-27

Regulatory

• FDA-regulated device study