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The objective of the study is to identify the relationship between patient position during surgery and time to confirmation of ureteral patency on cystoscopy.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 degree supine position | No Intervention | Surgical bed will be set to a 0 degree supine position | |
| 10-20 degree angle in reverse Trendelenburg | Experimental | Surgical bed will be set to a 10-20 degree angle in reverse Trendelenburg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Position | Other | The patient will be placed in an angle on the surgical table during cystoscopy. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamal Mourad, DO | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26551173 | Background | 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. | |
| 15902164 | Background | 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. |
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| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 1 day |
| delayed diagnosis of ureteric injury | evaluated 6 weeks postoperatively via chart review | 6 weeks after surgery |
| 15625150 | Background | 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. |
| 21886472 | Background | 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. |
| 15291852 | Background | 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. |
| 29369837 | Background | 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. |
| 25833482 | Background | 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. |
| 22748947 | Background | 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. |
| 36103970 | Derived | 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. |