An interventional study of Water and Saline in Ureteral Stricture, Hydronephrosis and Urothelial Carcinoma, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Emory University · Not applicable, Interventional, and Other
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.
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.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measurement will be performed day of ureteroscopy
Ran from Jan 2017 to primary completion in Dec 2017, 11 months.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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