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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03123315
Other study ID # CASE11815
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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)

Study Design


Related Conditions & MeSH terms


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
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