Hysterectomy
Conditions
Keywords
hysterectomy, ureter
Brief 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.
Interventions
DEVICEUreteral Illuminating Catheter
This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-Center Prospective Cohort
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary | Cross-sectional measurement at time of surgery | 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. |
| Distance from the ureter to the uterine vessels | Cross-sectional measurement at time of surgery | 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. |
| The distance from the ureter to the right gonadal vessel at the pelvic sidewall | Cross-sectional measurement at time of surgery | 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. |
| The distance from the ureter to the left gonadal vessel at the pelvic sidewall | Cross-sectional measurement at time of surgery | 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. |
| The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary | Cross-sectional measurement at time of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery | Cross-sectional measurement at time of surgery | 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. |
| To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery | Cross-sectional measurement at time of surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To determine thermal spread from a Harmonic device | Cross-sectional measurement immediately after surgery | 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 |
| To determine thermal spread from a Ligasure to show the | Cross-sectional measurement immediately after surgery | 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 |
Outcome results
None listed