Water Versus Saline as Irrigation Fluid for Ureteroscopy

NCT ID: NCT03794102

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-17

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Ureteral Stricture Hydronephrosis Urothelial Carcinoma Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Water

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Ogan, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Ogan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Grady Health System

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00005780

Identifier Type: -

Identifier Source: org_study_id

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