Water Versus Saline as Irrigation Fluid for Ureteroscopy

Not Applicable

Completed

• Conditions: Urolithiasis; Urothelial Carcinoma; Hydronephrosis; Ureteral Stricture
• Interventions: Other: Water; Other: Saline

• Registration Number: NCT03794102
• Lead Sponsor: Emory University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-17
• Primary Completion: 2017-12-22
• Study Completion: 2018-06-30
• Study First Submitted: 2018-12-21
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ureteroscopy with water irrigation	Water	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.
Ureteroscopy with saline irrigation	Saline	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.

Primary Outcome Measures

Name	Time	Method
Amount of irrigation fluid used during ureteroscopy	Measurement will be performed day of 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.
Change in serum sodium levels	Measurement will be performed day of ureteroscopy	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.
Surgeon's rating of ureteroscopic visualization	Measurement will be performed day of ureteroscopy	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 of fluid clarity	Measurement will be performed day of ureteroscopy	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.

Trial Locations

Locations (2)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States