Surgery--Complications, Ureteral Injury
Conditions
Keywords
ureteral injury, cystoscopy, hysterectomy, gynecologic surgery
Brief summary
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
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)
Interventions
OTHERPatient Position
The patient will be placed in an angle on the surgical table during cystoscopy.
Sponsors
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female patients 2. Greater than or equal to 18 years old 3. English-speaking 4. 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
1. Patients with underlying chronic kidney disease (creatinine \<1) 2. Known renal anomaly such as prior surgical removal of a kidney or underlying ureteral obstruction 3. Current ureteral stent in place, 4. Pregnancy, 5. Contraindication to any of the interventions (i.e., documented allergies)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to confirmation of bilateral ureteral patency | 1 day | time between initiation of cystoscopy and visualization of second ureteral jet in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total cystoscopy time | 1 day | Total time of cystoscopy |
| need for alternative modalities to aid in ureteral efflux visualization | 1 day | 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. |
| delayed diagnosis of ureteric injury | 6 weeks after surgery | evaluated 6 weeks postoperatively via chart review |
Countries
United States
Outcome results
None listed