Water Versus Saline as Irrigation Fluid for Ureteroscopy

NCT03794102 | Completed

• 1 other identifier: IRB00005780
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Ureteral Stricture; Hydronephrosis; Urothelial Carcinoma; Urolithiasis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Ureteroscopy with water irrigation

ACTIVE COMPARATOR

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

Ureteroscopy with saline irrigation

ACTIVE COMPARATOR

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

Interventions

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.

Ureteroscopy with water irrigation

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.

Ureteroscopy with saline irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hydronephrosis; Carcinoma, Transitional Cell; Urolithiasis

Interventions

Water; Sodium Chloride

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Kenneth Ogan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 4, 2019
• Study Start: January 17, 2017
• Primary Completion: December 22, 2017
• Study Completion: June 30, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

US (2)