The Use of Dye-less Cystoscopy in Assessing Urinary Tract Integrity During Hysterectomy
Condition: Hysterectomy; Cystoscopy
Study type: Interventional

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.
    

Intervention name(s): water as bladder distending media; intravenous dye; No intervention
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): water will be used for bladder dissension during cystoscopy; intravenous dye using methylene blue or fluorescein will be used for visual aid of ureteral jets during cystoscopy; Saline only, no dye
Allocation: Randomized
Intervention model: Parallel Assignment
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
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hysterectomy; universal cystoscopy; cystoscopy