Optimization of Ureterolysis During Hysterectomy

NCT03123315 | Withdrawn FDA Device

• 1 other identifier: CASE11815
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hysterectomy

Keywords

hysterectomy; ureter

Outcome Measures

Primary Outcomes (5)

• Distance from the ureter to the uterine vessels

  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.

  Cross-sectional measurement at time of surgery

• The distance from the ureter to the right gonadal vessel at the pelvic sidewall

  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.

  Cross-sectional measurement at time of surgery

• The distance from the ureter to the left gonadal vessel at the pelvic sidewall

  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.

  Cross-sectional measurement at time of surgery

• The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary

  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.

  Cross-sectional measurement at time of surgery

• The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary

  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.

  Cross-sectional measurement at time of surgery

Secondary Outcomes (2)

• 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 infundibulopelvic ligament which had Harmonic electrosurgery

  Cross-sectional measurement at time of surgery

Other Outcomes (2)

• To determine thermal spread from a Ligasure to show the

  Cross-sectional measurement immediately after surgery

• To determine thermal spread from a Harmonic device

  Cross-sectional measurement immediately after surgery

Study Arms (1)

Cook Bush DL™ Ureteral Illuminating Catheter

EXPERIMENTAL

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.

Device: Ureteral Illuminating Catheter

Interventions

Ureteral Illuminating Catheter DEVICE

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

Also known as: ureteral stent

Cook Bush DL™ Ureteral Illuminating Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Officials

• Robert Debernardo, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-Center Prospective Cohort

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 21, 2017
• Study Start: April 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 27, 2018

Record last verified: 2018-02