HysterectomyNCT03123315
Optimization of Ureterolysis During Hysterectomy
A study testing Ureteral Illuminating Catheter in people with Hysterectomy, run by Case Comprehensive Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Ureteral Illuminating Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: 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.
Read the 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
- Being tested
- Ureteral Illuminating Catheter
- Keywords
- hysterectomy, ureter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral Illuminating CatheterDevice
Also called ureteral stent
This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ureteral Illuminating Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Cross-sectional measurement at time of surgery
Secondary outcomes (2)
To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery
To determine the burst pressure of segments of IP ligament that have undergone Ligasure electrosurgery. The Ligasure electrosurgery cuts and seals the tissue during surgery. The burst pressure gives a measure of how well the tissue is sealed.
Measured: Cross-sectional measurement at time of surgery
To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery
To determine the burst pressure of segments of IP ligament that have undergone Harmonic electrosurgery. The Harmonic electrosurgery cuts and seals the tissue during surgery. The burst pressure gives a measure of how well the tissue is sealed.
Measured: Cross-sectional measurement at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startApr 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: per PI request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Center Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Debernardo, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123315
- Sponsor's protocol ID
- CASE11815
- Status last verified
- Feb 2018
- First submitted
- 14 Apr 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Parameters for Ureterolysis During Minimally Invasive Hysterectomy; Determining Variation in Ureter Position and Degree of Thermal Spread
- ClinicalTrials.gov ID
- NCT03123315
- Acronym / sponsor ID
- CASE11815
- Conditions
- Hysterectomy
- Keywords
- hysterectomy, ureter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: per PI request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Center Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| Cook Bush DL™ Ureteral Illuminating Catheter | Experimental | Device: Ureteral Illuminating CatheterAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteral Illuminating CatheterAlso: ureteral stentThis is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries | Device | Cook Bush DL™ Ureteral Illuminating Catheter |
Primary outcome
Distance from the ureter to the uterine vessels
Time frame: Cross-sectional measurement at time of surgery
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.
The distance from the ureter to the right gonadal vessel at the pelvic sidewall
Time frame: Cross-sectional measurement at time of surgery
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.
The distance from the ureter to the left gonadal vessel at the pelvic sidewall
Time frame: Cross-sectional measurement at time of surgery
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.
The distance from the ureter to the right gonadal vessel where the gonadal vessel enter in to the ovary
Time frame: Cross-sectional measurement at time of surgery
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.
The distance from the ureter to the left gonadal vessel where the gonadal vessel enter in to the ovary
Time frame: Cross-sectional measurement at time of surgery
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.
2 secondary outcomes
To determine the burst pressure of infundibulopelvic (IP) ligament which had Ligasure electrosurgery
Time frame: Cross-sectional measurement at time of surgery
To determine the burst pressure of infundibulopelvic ligament which had Harmonic electrosurgery
Time frame: Cross-sectional measurement at time of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Debernardo, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral Illuminating Catheter in people with Hysterectomy, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance from the ureter to the uterine vessels (time frame: Cross-sectional measurement at time of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.