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Trial record 8 of 20 for:    Stents | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Quality of Life in Kidney Stone Patients Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT02625051
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Kidney Calculi Quality of Life Procedure: Ureteroscopy Procedure: Percutaneous nephrolithotomy Device: Ureteral stent (double-J stent) Device: Percutaneous nephrostomy tube Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial Comparing Ureteroscopic to Percutaneous Removal for the 1-2 cm Calculus Measuring Quality of Life as the Primary Outcome
Study Start Date : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: Ureteroscopy
Kidney stone of participants in this arm will be treated with ureteroscopy (URS). A ureteral stent will be inserted at the end of the procedure.
Procedure: Ureteroscopy
Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. A safety guide-wire is then placed into renal pelvis, followed by a ureteral access sheath to maintain low intra-renal pressure, and to facilitate the procedures. Using flexible ureteroscope, renal or proximal ureteral stone is identified and fragmented with a holmium laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.
Other Name: URS

Device: Ureteral stent (double-J stent)
After ureteroscopy (URS) is done and stone clearance is achieved, a 4.6 french ureteral stent is routinely placed at the end of the procedure to drain the kidney for 1-3 weeks.
Other Name: DJ stent

Active Comparator: Percutaneous nephrolithotomy
Kidney stone of participants in this arm will be treated with percutaneous nephrolithotomy (PNL). A percutaneous nephrostomy tube will be inserted at the end of the procedure.
Procedure: Percutaneous nephrolithotomy
Under general anesthesia, an open-ended 5 french ureteral exchange catheter is placed into the ipsilateral ureter under cystoscopic guidance. The patient is then safely turned and secured in the prone position. Percutaneous renal access is obtained under ultrasonographic or fluoroscopic guidance. Either a 24 or 30 french sheath is advanced in the kidney and nephroscopy is performed with a rigid offset nephroscope. Stone fragmentation is accomplished using a dual CyberWand lithotripter or holmium laser lithotripsy. Flexible nephroscopy is performed to look for possible residual fragments and basket extraction is done for complete clearance of stone.
Other Name: PNL

Device: Percutaneous nephrostomy tube
At the end of the percutaneous nephrolithotomy (PNL) procedure, a 10 french Cope loop percutaneous nephrostomy tube is placed in all patients to drain the kidney for 1-2 days.
Other Name: PCN




Primary Outcome Measures :
  1. Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at early postoperative period [ Time Frame: Change from baseline score at 1 week after surgery ]
    This instrument consisted of 36 questions with response ranging from 0 (poor QOL) to 100 (best QOL).


Secondary Outcome Measures :
  1. Change of overall quality of life (QOL) score as measured by Ureteral Stent Symptom Questionnaire (USSQ) at early postoperative period [ Time Frame: Change from baseline score at 1 week after surgery ]
    This instrument consisted of 38 questions in 6 non-uniformed categories with response ranging from the least (best QOL) to the most (poor QOL).


Other Outcome Measures:
  1. Change of overall quality of life (QOL) score as measured by Short form-36 (SF-36) Questionnaire at late postoperative period [ Time Frame: Change from baseline score at 3 months after surgery ]
    This instrument consisted of 36 questions with response ranging from 0 (poor QOL) to 100 (best QOL).

  2. Change of overall quality of life (QOL) score as measured by Ureteral Stent Symptom Questionnaire (USSQ) at late postoperative period [ Time Frame: Change from baseline score at 3 months after surgery ]
    This instrument consisted of 38 questions in 6 non-uniformed categories with response ranging from the least (best QOL) to the most (poor QOL).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625051


Contacts
Contact: Thomas Chi, MD 415-353-2480 tom.chi@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Thomas Chi, MD    415-353-2480    tom.chi@ucsf.edu   
Contact: Victoria Hogue, MA       Victoria.Hogue@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Thomas Chi, MD University of California, San Francisco

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02625051     History of Changes
Other Study ID Numbers: CHR15-17595
P20DK100863 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi