The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy

Not Applicable

Completed

• Conditions: Cystoscopy; Hysterectomy
• Interventions: Diagnostic Test: intravenous dye; Diagnostic Test: No intervention; Diagnostic Test: water as bladder distending media

• Registration Number: NCT05190939
• Lead Sponsor: WellSpan Health

Brief Summary

An investigation comparing the reliability of dye-aided versus dye-less evaluation of urinary tract integrity during intra-operative cystoscopy among patients undergoing hysterectomy.

Detailed Description

Surgical injury to the urinary bladder and ureters is a recognized hazard with gynecologic procedures. Overall incidence is low; however, undetected injury to the bladder or ureter can be associated with avoidable morbidity. Approximately 75 to 85% of ureteral injuries are detected postoperatively. Various techniques have been investigated to prevent or detect genitourinary tract injuries during gynecologic surgery. Cystoscopy has been shown to increase the detection rate of urinary tract injury during gynecologic procedures compared to visual detection.

Intra-operative detection of urinary tract injury enables primary repair with high rates of success and avoidance of morbidity. Currently however, there is no standard recommendation for the routine use of cystoscopy in general gynecologic surgeries or in patients undergoing hysterectomy for gynecologic malignancies. Cost appears to be the main reason for the lack of a policy level endorsement of routine cystoscopy. One analysis concluded that ureteral injury rate was too low to justify routine cystoscopy, however other studies have reported higher urinary tract injury rates than previously published data, noted especially with the increasing use minimally invasive surgery.

Removal of dye usage with cystoscopy can help mitigate the issue of cost associated with routine cystoscopy. Various dye agents are used to aid in the visualization of urine efflux. Multiple studies have evaluated the pros and cons of these dyes. The ability to perform cystoscopy without dye would decrease cost, if the accuracy of urinary tract injury identification is not compromised. The primary objective of this study is to assess the accuracy of dye-less cystoscopy in the detection of urinary tract injury following hysterectomy. The investigators hypothesize that accurate cystoscopic evaluation for urinary tract injury at hysterectomy can be accomplished without the use of dye.

This study is a randomized prospective evaluation in which patients undergoing hysterectomy for both benign and malignant conditions are randomized into one of four study arms: 1) dye/saline 2) dye/water 3) no-dye/saline and 4) no-dye/water. Following completion of hysterectomy patients undergo routine cystoscopy utilizing distending media and dye (or no dye) according to their assigned randomization. Two independent and blinded evaluations of the bilateral ureteral jet strengths is then performed using a continuous visual scale scoring system. Ureteral jet strength scores are then evaluated for inter-observer correlation as well as comparison of jet strength and time until initial ureteral jetting is seen between the four randomized arms.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-12-29
• Study Completion: 2019-12-29
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

Inclusion Criteria

• Subjects at least 18 years of age and less than 90 years of age able to give informed consent
• Subjects undergoing hysterectomy for benign or malignant indications

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Exclusion Criteria

• Pregnancy or planned fertility
• Inability to provide informed consent
• Subject is not a surgical candidate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dye/saline	intravenous dye	Subjects assigned to the dye/saline group will have cystoscopy performed using saline as the bladder distending media and will utilize intravenous dye (methylene blue or fluorescein) as a ureteral jet visualization aid
no-dye/saline	No intervention	Subjects assigned to the no-dye/saline group will have cystoscopy performed using saline as the bladder distending media and will not utilize any intravenous dye
dye/water	water as bladder distending media	Subjects assigned to the dye/water group will have cystoscopy performed using water as the bladder distending media and will utilize intravenous dye (methylene blue or fluorescein) as a ureteral jet visualization aid
no-dye/water	water as bladder distending media	Subjects assigned to the no-dye/water group will have cystoscopy performed using water as the bladder distending media and will not utilize any intravenous dye
dye/water	intravenous dye	Subjects assigned to the dye/water group will have cystoscopy performed using water as the bladder distending media and will utilize intravenous dye (methylene blue or fluorescein) as a ureteral jet visualization aid

Primary Outcome Measures

Name	Time	Method
Inter-observer correlation of urine efflux strength during cystoscopy	at time of cystoscopy	Observers visually assess ureters on-screen simultaneously and independently. Ureteral jet efflux from each ureter is assigned a score on a linear visual scale from 0 to 5. The best of three scores of three consecutive jets from each ureter is assigned as the strength of ureteral jet. On a continuous visual scale, absent efflux is assigned as zero, slow or impaired efflux is assigned up to a score of 2, average flow neither sluggish nor brisk is assigned at least 2, and brisk flow is assigned a score of at least 3 and up to a score of 5. Evaluators determine if efflux is greater than 2. If so, evaluators are instructed to determine if efflux is 3 or 5- jets scored as 3 represent regular stream flow with no intermittent breaks and jets scored as 5 represented continuous strong flow. A score of 4 is given if the urine jet flow did not meet the criteria for a scoring of 3 or 5. Correlation of score agreement between observers and group assignments is then determined.

Secondary Outcome Measures

Name	Time	Method
Ureteral jet time	at time of cystoscopy	Time until initial ureteral jet is observed between groups based on dye use distending media
Comparison of ureteral jet strength between groups based group assignment	at time of cystoscopy	At time of cystoscopy ureteral jet strength is compared between the group assignments based on distending media and dye or no dye. Ureteral jet strength is measured using a continuous visual scale as with the primary outcome however the outcome focus is absolute ureteral jet strength rather than inter-observer correlation of jet strength.

Trial Locations

Locations (1)

Wellspan Health; 🇺🇸 York, Pennsylvania, United States