Ureteral Jets and Patient Positioning Study

Study Overview
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Brief Summary
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The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.

Detailed Description
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Patients will be randomized to one of two arms: 0 degree supine position and 10-20 degree angle in reverse Trendelenburg. Our working hypothesis is that positioning a patient in 10-20 degree angle reverse Trendelenburg will result in shorter time to confirmation of bilateral ureteral patency and shorter total cystoscopy time, without a change in delayed diagnosis of ureteric injury. Primary outcome: time to confirmation of bilateral ureteral patency Secondary outcome: total cystoscopy time, need for alternative modalities to aid in ureteral efflux visualization, delayed diagnosis of ureteric injury (evaluated 6 weeks postoperatively via chart review)

Official Title
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The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: a Randomized Controlled Trial

Conditions
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Ureteral Injury, Surgery--Complications

Intervention / Treatment
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* Other: Patient Position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients Greater than or equal to 18 years old English-speaking Scheduled benign gynecologic or urogynecologic surgery in which routine cystoscopy at Banner University Medical Center - Phoenix; Dr. Mourad, Dr. Mahnert or Dr. Rachael Smith. Exclusion Criteria: Patients with underlying chronic kidney disease (creatinine <1) Known renal anomaly such as prior surgical removal of a kidney or underlying ureteral obstruction Current ureteral stent in place, Pregnancy, Contraindication to any of the interventions (i.e., documented allergies)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 0 degree supine position<br>Surgical bed will be set to a 0 degree supine position | |
| Experimental: 10-20 degree angle in reverse Trendelenburg<br>Surgical bed will be set to a 10-20 degree angle in reverse Trendelenburg | Other: Patient Position<br>* The patient will be placed in an angle on the surgical table during cystoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to confirmation of bilateral ureteral patency | time between initiation of cystoscopy and visualization of second ureteral jet in minutes | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cystoscopy time | Total time of cystoscopy | 1 day | 
| need for alternative modalities to aid in ureteral efflux visualization | After 10 minutes of no jet, it is okay for the surgeon to use alternative methods, including dextrose, sodium fluorescein, indigo carmine, IV diuretics, etc. | 1 day | 
| delayed diagnosis of ureteric injury | evaluated 6 weeks postoperatively via chart review | 6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral injury, cystoscopy, hysterectomy, gynecologic surgery