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per PI request
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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.
Objectives:
Primary: (While uterus is under tension)
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook Bush DLâ„¢ Ureteral Illuminating Catheter | Experimental | As part of this study an additional tool will be used during the hysterectomy. This tool is called a Cook Bush DLâ„¢ 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteral Illuminating Catheter | Device | This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries |
|
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Debernardo, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
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Single-Center Prospective Cohort
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| 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 |
| 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 |
| 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 |