Ureteral Jets and Patient Positioning Study

NCT04732403 | Completed

• 1 other identifier: 2011188102
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Injury; Surgery--Complications

Keywords

ureteral injury; cystoscopy; hysterectomy; gynecologic surgery

Outcome Measures

Primary Outcomes (1)

• time to confirmation of bilateral ureteral patency

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

  1 day

Secondary Outcomes (3)

• total cystoscopy time

  1 day

• need for alternative modalities to aid in ureteral efflux visualization

  1 day

• delayed diagnosis of ureteric injury

  6 weeks after surgery

Study Arms (2)

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

Other: Patient Position

Interventions

Patient Position OTHER

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

10-20 degree angle in reverse Trendelenburg

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (9)

• 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.

  PMID: 26551173 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.

  PMID: 15902164 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.

  PMID: 15625150 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.

  PMID: 21886472 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.

  PMID: 15291852 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.

  PMID: 29369837 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.

  PMID: 25833482 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.

  PMID: 22748947 BACKGROUND

• 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.

  PMID: 36103970 DERIVED

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jamal Mourad, DO

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: February 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 1, 2022
• Last Updated: November 1, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)