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Completed

NCT Number: NCT04732403

Ureteral Jets and Patient Positioning Study

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

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Key information

Conditions

Ureteral Injury Surgery--Complications

Age range

18 year–89 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

patient position

Other

The patient will be placed in an angle on the surgical table during cystoscopy.

Primary outcomes

  1. time to confirmation of bilateral ureteral patency

    Time frame: 1 day

    time between initiation of cystoscopy and visualization of second ureteral jet in minutes

Secondary outcomes

  1. total cystoscopy time

    Time frame: 1 day

    Total time of cystoscopy

  2. need for alternative modalities to aid in ureteral efflux visualization

    Time frame: 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.

  3. delayed diagnosis of ureteric injury

    Time frame: 6 weeks after surgery

    evaluated 6 weeks postoperatively via chart review

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2021
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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