Ureteral Jets and Patient Positioning Study

Not Applicable

Completed

• Conditions: Surgery--Complications; Ureteral Injury
• Interventions: Other: Patient Position

• Registration Number: NCT04732403
• Lead Sponsor: University of Arizona

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)

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-27
• Study Start: 2021-02-01
• Study First Posted: 2021-02-01
• Status Verified: 2021-06
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-01
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10-20 degree angle in reverse Trendelenburg	Patient Position	Surgical bed will be set to a 10-20 degree angle in reverse Trendelenburg

Primary Outcome Measures

Name	Time	Method
time to confirmation of bilateral ureteral patency	1 day	time between initiation of cystoscopy and visualization of second ureteral jet in minutes

Secondary Outcome Measures

Name	Time	Method
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.
total cystoscopy time	1 day	Total time of cystoscopy
delayed diagnosis of ureteric injury	6 weeks after surgery	evaluated 6 weeks postoperatively via chart review

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States