Ureteral Jets and Patient Positioning Study

University of Arizona

Status: Completed

Conditions: Surgery--Complications; Ureteral Injury

Treatments: Other: Patient Position

Study type: Interventional

Funder types: Other

Identifiers

NCT04732403

2011188102

Details and patient eligibility

About

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

Full 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)

Enrollment: 91 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

0 degree supine position

No Intervention group

Description:

Surgical bed will be set to a 0 degree supine position

10-20 degree angle in reverse Trendelenburg

Experimental group

Description:

Surgical bed will be set to a 10-20 degree angle in reverse Trendelenburg

Treatment:

Other: Patient Position