Optimization of Ureterolysis During Hysterectomy

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Hysterectomy

Treatments: Device: Ureteral Illuminating Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03123315

CASE11815

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Cook Bush DL™ Ureteral Illuminating Catheter

Experimental group

Description:

As part of this study an additional tool will be used during the hysterectomy. This tool is called a Cook Bush DL™ 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.

Treatment:

Device: Ureteral Illuminating Catheter