Optimization of Ureterolysis During Hysterectomy

NCT ID: NCT03123315

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2020-06-30

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.

Conditions

Hysterectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cook Bush DL™ Ureteral Illuminating Catheter

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.

Group Type: EXPERIMENTAL

Ureteral Illuminating Catheter

Intervention Type: DEVICE

This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries

Interventions

Ureteral Illuminating Catheter

This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries

Intervention Type: DEVICE

Other Intervention Names

ureteral stent

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Debernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Other Identifiers

CASE11815

Identifier Type: -

Identifier Source: org_study_id