Optimization of Ureterolysis During Hysterectomy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hysterectomy
• Intervention / Treatment: Device: Ureteral Illuminating Catheter

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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; Other Names: ureteral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance from the ureter to the uterine vessels	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.	Cross-sectional measurement at time of surgery
The distance from the ureter to the right gonadal vessel at the pelvic sidewall	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.	Cross-sectional measurement at time of surgery
The distance from the ureter to the left gonadal vessel at the pelvic sidewall	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.	Cross-sectional measurement at time of surgery
The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary	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.	Cross-sectional measurement at time of surgery
The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary	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.	Cross-sectional measurement at time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery	To determine the burst pressure of segments of IP ligament that have undergone Ligasure electrosurgery. The Ligasure electrosurgery cuts and seals the tissue during surgery. The burst pressure gives a measure of how well the tissue is sealed.	Cross-sectional measurement at time of surgery
To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery	To determine the burst pressure of segments of IP ligament that have undergone Harmonic electrosurgery. The Harmonic electrosurgery cuts and seals the tissue during surgery. The burst pressure gives a measure of how well the tissue is sealed.	Cross-sectional measurement at time of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine thermal spread from a Ligasure to show the	Thermal spread is the dispersal of heat into surrounding tissue during electrosurgeries, causing damage to the tissue.In order to measure thermal spread, the gonadal vessels will be harvested after the specimen (uterus, tubes, ovaries and cervix) has been removed from the patient	Cross-sectional measurement immediately after surgery
To determine thermal spread from a Harmonic device	Thermal spread is the dispersal of heat into surrounding tissue during electrosurgeries, causing damage to the tissue. In order to measure thermal spread, the gonadal vessels will be harvested after the specimen (uterus, tubes, ovaries and cervix) has been removed from the patient	Cross-sectional measurement immediately after surgery

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Robert Debernardo, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 24, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: hysterectomy; ureter
• Other Study ID Numbers: CASE11815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes