Water Versus Saline as Irrigation Fluid for Ureteroscopy

Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794102
• Other study ID #: IRB00005780
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2018
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years of age

• Participants meeting medical requirements to undergo ureteroscopy

Exclusion Criteria:

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Hydronephrosis
• Ureteral Stricture
• Urolithiasis
• Urothelial Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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