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Prospective, Randomized Study to Assess Patient Satisfaction and Stone Free Effect of High Powered Stone Dusting vs. Fragmentation and Basketing at Time of Ureteroscopy


Description

The purpose of this study is to determine the differences in stone free results, patient side effects, and patient satisfaction between dusting vs. basket extraction for kidney and ureteral stones (a kidney stone located in the tube between the kidney and bladder) 6 mm and greater in size undergoing ureteroscopic treatment. Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. Basket extraction is when a small wire basket is used to remove stone fragments.On the day of surgery, the treatment assigned to the patient will be determined by chance, like flipping a coin. Neither the patient nor the study doctor will choose the treatment type. Each patient will have an equal chance of being given either surgical treatment. One group will have stones treated with high-powered laser dusting and the dust produced will pass spontaneously through the urine. The other group will have stones treated with low power laser fragmentation and

Trial Eligibility

Inclusion Criteria: * \>18 years of age * undergoing ureteroscopic stone extraction * Stone size 6mm stones or greater and the location to mid ureter or higher * Willing to sign informed consent form * Able to read, understand, and complete patient questionnaires, and pain questionnaires Exclusion Criteria: * \< 18 years of age * Inability to provide informed consent * Concomitant surgery (i.e. Percutaneous nephrolithotomy, Holmium laser enucleation of the prostate * Solitary kidney * Nephrocalcinosis * Members of vulnerable patient populations * Patients without access to a phone that can receive txt messages

Study Info

Organization

Northwestern University


Primary Outcome

Stone free rate: clinical


Outcome Timeframe 6 weeks

NCTID NCT05006937

Phases NA

Primary Purpose TREATMENT

Start Date 2021-07-28

Completion Date 2023-07-01

Enrollment Target 168

Interventions

PROCEDURE Dusting

PROCEDURE Basket extraction

Locations Recruiting

Northwestern Memorial Hospital

United States, Illinois, Chicago


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