Skip to main content
OpenTrials
Completed

NCT Number: NCT03794102

Water Versus Saline as Irrigation Fluid for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ureteral Stricture Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Urogenital Diseases Urolithiasis Urologic Diseases Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Water

Other

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

Other

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.

Primary outcomes

  1. Amount of irrigation fluid used during ureteroscopy

    Time frame: 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.

  2. Change in serum sodium levels

    Time frame: 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.

  3. Surgeon's rating of ureteroscopic visualization

    Time frame: 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.

  4. Measurement of fluid clarity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 4, 2019
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.