Clinical trial NCT05190939: The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy
Official title: The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterectomy
Cystoscopy
Keywords: hysterectomy
universal cystoscopy
cystoscopy
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing hysterectomy are randomized to one of 4 study arms for cystoscopy: 1) dye/saline 2) dye/water 3) no-dye/saline and 4) no-dye/water
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Inter-observer correlation of urine efflux strength during cystoscopy
timeFrame: at time of cystoscopy
Secondary outcomes:
measure: Comparison of ureteral jet strength between groups based group assignment
timeFrame: at time of cystoscopy
measure: Ureteral jet time
timeFrame: at time of cystoscopy
Other outcomes:
Locations:
city: York
country: United States
facility: Wellspan Health
state: Pennsylvania
Study officials:
affiliation: WellSpan Health
name: Okechukwu Ibeanu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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