Optimization of Ureterolysis During Hysterectomy
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/22/2017 |
| Start Date: | December 2017 |
| End Date: | June 2020 |
| Contact: | Robert Debernardo, MD |
| Email: | debernr@ccf.org |
| Phone: | 216-444-7645 |
Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread
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.
hysterectomy) by better understanding where a patient's ureters lie.
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.
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.
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)
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Principal Investigator: Robert Debernardo, MD
Phone: 216-444-7645
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