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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hysterectomy Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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no-dye/saline

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

Group Type ACTIVE_COMPARATOR