Ureteral Jets and Patient Positioning Study

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

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

Study Overview

• Status: Completed
• Conditions: Surgery--Complications; Ureteral Injury
• Intervention / Treatment: Other: Patient Position

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Jamal Mourad, DO, University of Arizona

Publications and helpful links

General Publications

• Teeluckdharry B, Gilmour D, Flowerdew G. Urinary Tract Injury at Benign Gynecologic Surgery and the Role of Cystoscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Dec;126(6):1161-1169. doi: 10.1097/AOG.0000000000001096.
• Vakili B, Chesson RR, Kyle BL, Shobeiri SA, Echols KT, Gist R, Zheng YT, Nolan TE. The incidence of urinary tract injury during hysterectomy: a prospective analysis based on universal cystoscopy. Am J Obstet Gynecol. 2005 May;192(5):1599-604. doi: 10.1016/j.ajog.2004.11.016.
• Gilmour DT, Baskett TF. Disability and litigation from urinary tract injuries at benign gynecologic surgery in Canada. Obstet Gynecol. 2005 Jan;105(1):109-14. doi: 10.1097/01.AOG.0000144127.78481.8c.
• Delacroix SE Jr, Winters JC. Urinary tract injuries: recognition and management. Clin Colon Rectal Surg. 2010 Sep;23(3):221. doi: 10.1055/s-0030-1263063. No abstract available.
• Brandes S, Coburn M, Armenakas N, McAninch J. Diagnosis and management of ureteric injury: an evidence-based analysis. BJU Int. 2004 Aug;94(3):277-89. doi: 10.1111/j.1464-410X.2004.04978.x. No abstract available.
• Cohen SA, Carberry CL, Smilen SW. American Urogynecologic Society Consensus Statement: Cystoscopy at the Time of Prolapse Repair. Female Pelvic Med Reconstr Surg. 2018 Jul/Aug;24(4):258-259. doi: 10.1097/SPV.0000000000000529.
• Kim JH. Urogynecology and Reconstructive Pelvic Surgery. 4th ed. Int Neurourol J. 2015 Mar;19(1):51. doi: 10.5213/inj.2015.19.1.51. No abstract available.
• AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL Practice Report: Practice guidelines for intraoperative cystoscopy in laparoscopic hysterectomy. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):407-11. doi: 10.1016/j.jmig.2012.05.001.
• Galhotra S, Zeng K, Hu C, Norton T, Mahnert N, Smith R, Mourad J. The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2023 Jan;30(1):13-18. doi: 10.1016/j.jmig.2022.09.003. Epub 2022 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: gynecologic surgery; hysterectomy; cystoscopy; ureteral injury
• Other Study ID Numbers: 2011188102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No