Ureteral Jets and Patient Positioning Study

Surgery--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732403
• Other study ID #: 2011188102
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 2022

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: Sheena Galhotra, MD
• Phone: 6027967457
• Email: sheena.galhotra[@]bannerhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Surgery--Complications
• Ureteral Injury

Intervention

Other:
• Patient Position
The patient will be placed in an angle on the surgical table during cystoscopy.

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to confirmation of bilateral ureteral patency	time between initiation of cystoscopy and visualization of second ureteral jet in minutes	1 day
Secondary	total cystoscopy time	Total time of cystoscopy	1 day
Secondary	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
Secondary	delayed diagnosis of ureteric injury	evaluated 6 weeks postoperatively via chart review	6 weeks after surgery