Quality of Life in Kidney Stone Patients Undergoing Surgery



Status:Recruiting
Conditions:Nephrology, Nephrology, Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:7/27/2017
Start Date:July 2016
End Date:December 2018
Contact:Thomas Chi, MD
Email:tom.chi@ucsf.edu
Phone:415-353-2480

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Randomized Controlled Clinical Trial Comparing Ureteroscopic to Percutaneous Removal for the 1-2 cm Calculus Measuring Quality of Life as the Primary Outcome

This is a prospective randomized study, comparing quality of life in renal stone patients
undergoing surgical treatment with ureteroscopy (URS) versus percutaneous nephrolithotomy
(PNL).

In United States, the prevalence of renal stone is 8.8% with slight predomination in male
than female. They can be symptomatic marked by symptoms of flank pain, hematuria or urinary
tract infection, or completely asymptomatic and incidentally discovered. Three modalities are
accepted as treatment options for renal stone, including shockwave lithotripsy (SWL),
percutaneous nephrolithotomy (PNL) and ureteroscopy (URS). While some standard guidelines
were proposed for appropriate treatment selection with regard to stone size, no
recommendations or guidelines exist for the surgical management of 1-2 cm renal stones. Both
PNL and URS are equally accepted as treatment options for stones at this size. The selection
of either procedure currently is left to the treating surgeon can be influenced by anatomical
or stone factors as well as patient preference. For URS, frequent requirement for
postoperative ureteral stents may result in significant morbidity and a detriment to quality
of life owing to irritating bladder symptoms caused by the stent itself. PNL rarely requires
postoperative ureteral stent but it may bring longer operative time and hospitalization. PNL
therefore may be a treatment option that preserves quality of life compared to URS for
patients presenting with the 1-2 cm sized kidney or ureteral stone.

One reasonable way to evaluate efficacy of treatment options is to assess patient's quality
of life resultant from the selected modality. Quality of life for renal stone formers is an
important but under-studied facet of nephrolithiasis management that should be incorporated
into clinical decision making.

The short form-36 health survey questionnaire (SF-36) is a patient-reported survey of health
status. It has been validated and is commonly used to determine the efficacy of a given
health treatment in many settings, including urologic intervention. The Ureteral Stent
Symptom Questionnaire (USSQ) is a validated and widely accepted instrument to evaluate the
impact of ureteral stents on quality of life. The investigators plan to use these two
questionnaires as a standard outcome measurement to compare impact on quality of life in
patients randomized to undergo two different modalities (PNL versus URS) of stone treatment.

Inclusion Criteria:

- Patient with a renal or proximal ureteral stone measuring 1-2 cm in size on
preoperative ultrasound, computed tomography, or plain radiographic imaging

Exclusion Criteria:

- Serious illness likely to cause death within the next 5 years, so as to exclude
significant metabolic derangements that might lead to adverse surgical outcome.

- Stones with measured size larger than 2 cm or smaller than 1 cm.

- Patients with ureteral or renal anatomy or stones located in a position judged to be
unsafe for randomization.

- Pregnancy.
We found this trial at
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San Francisco, California 94143
Phone: 415-353-2480
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