Water Versus Saline as Irrigation Fluid for Ureteroscopy

The Effects of Water Versus Saline on Absorption Rates and Visualization During Ureteroscopy

The purpose of this study is to determine the rate of absorption of fluids (water or saline) during ureteroscopy and to assess the effects on electrolyte levels. The investigators also want to measure how much better the urologist can see the ureter based on the type of irrigation fluid that is used.

Study Overview

• Status: Completed
• Conditions: Urolithiasis; Urothelial Carcinoma; Hydronephrosis; Ureteral Stricture
• Intervention / Treatment: Other: Water; Other: Saline

Detailed Description

The use of fluid irrigation is important during urologic procedures. There is little research done on the use of water versus saline for irrigation during ureteroscopy.

This study will evaluate whether the use of water or saline during ureteroscopy has any clinical implications. The investigators will compare the amount of fluid absorbed and differences in electrolytes between the two participant groups.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30303
      • Grady Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 18 years of age
• Participants meeting medical requirements to undergo ureteroscopy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ureteroscopy with water irrigation; Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Water will be used as the irrigation fluid during the ureteroscopy.	Other: Water; Sterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
Active Comparator: Ureteroscopy with saline irrigation; Participants meeting medical requirements to undergo ureteroscopy will undergo a routine cystoscopy and ureteroscopy following standard techniques. Saline will be used as the irrigation fluid during the ureteroscopy.	Other: Saline; 0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of irrigation fluid used during ureteroscopy	At conclusion of the ureteroscopy, the bag with the remaining fluid will be weighed to determine amount of fluid used. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.	Measurement will be performed day of ureteroscopy
Change in serum sodium levels	Blood samples will be drawn preoperatively and at conclusion of case (prior to awakening the participant) to assess the serum sodium levels (mEq/L). The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.	Measurement will be performed day of ureteroscopy
Surgeon's rating of ureteroscopic visualization	The surgeon will be asked to rate the degree of ureteroscopic visualization on a scale of 1-5, where 1=Poor visualization and 5= Excellent visualization. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.	Measurement will be performed day of ureteroscopy
Measurement of fluid clarity	Fluid clarity was assessed by taking turbidity (cloudiness) measurements of renal fluid (in nephelometric turbidity units (NTU)) with a turbidimeter. The average of three measurements of turbidity was used at the fluid clarity measurement of each case, to supplement the ureteroscopic visualization measurement by surgeon rating. The study will last from the start to the completion of the ureteroscopy, i.e. the duration of the ureteroscopic evaluation.	Measurement will be performed day of ureteroscopy

Collaborators and Investigators

• Sponsor: Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): December 22, 2017
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urolithiasis; Hydronephrosis
• Other Study ID Numbers: IRB00005780

Drug and device information, study documents

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