Clinical trial NCT03123315: Optimization of Ureterolysis During Hysterectomy
Official title: Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hysterectomy
Keywords: hysterectomy
ureter
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Center Prospective Cohort
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Distance from the ureter to the uterine vessels
timeFrame: Cross-sectional measurement at time of surgery
measure: The distance from the ureter to the right gonadal vessel at the pelvic sidewall
timeFrame: Cross-sectional measurement at time of surgery
measure: The distance from the ureter to the left gonadal vessel at the pelvic sidewall
timeFrame: Cross-sectional measurement at time of surgery
measure: The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary
timeFrame: Cross-sectional measurement at time of surgery
measure: The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary
timeFrame: Cross-sectional measurement at time of surgery
Secondary outcomes:
measure: To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery
timeFrame: Cross-sectional measurement at time of surgery
measure: To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery
timeFrame: Cross-sectional measurement at time of surgery
Other outcomes:
measure: To determine thermal spread from a Ligasure to show the
timeFrame: Cross-sectional measurement immediately after surgery
measure: To determine thermal spread from a Harmonic device
timeFrame: Cross-sectional measurement immediately after surgery
Locations:
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Robert Debernardo, MD
role: PRINCIPAL_INVESTIGATOR
References: