Optimization of Ureterolysis During Hysterectomy

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03123315
• Other study ID #: CASE11815
• Status: Withdrawn
• Phase: N/A
• First received: April 14, 2017
• Last updated: February 24, 2018
• Start date: April 2018
• Est. completion date: June 2020

Study information

• Verified date: February 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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