Clinical trial NCT04732403: Ureteral Jets and Patient Positioning Study
Official title: The Effect of Patient Positioning on Ureteral Efflux During Intraoperative Cystoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Injury
Surgery--Complications
Keywords: ureteral injury
cystoscopy
hysterectomy
gynecologic surgery
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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)

Primary outcomes:
measure: time to confirmation of bilateral ureteral patency
timeFrame: 1 day
Secondary outcomes:
measure: total cystoscopy time
timeFrame: 1 day
measure: need for alternative modalities to aid in ureteral efflux visualization
timeFrame: 1 day
measure: delayed diagnosis of ureteric injury
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: University of Arizona
name: Jamal Mourad, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.ajog.2004.11.016.
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. doi: 10.1097/01.AOG.0000144127.78481.8c.
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. No abstract available.
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. doi: 10.1111/j.1464-410X.2004.04978.x. No abstract available.
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.
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. No abstract available.
citation: 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.
citation: 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.