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Are the Stone Density and Location Useful Parameters for Small Kidney Stones?

Primary Purpose

Kidney Calculi, Kidney Stone

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mini percutaneous nephrolithotomy
Retrograde intrarenal surgery
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Calculi

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
  • Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.

Exclusion Criteria:

  • Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mini percutaneous nephrolithotomy

    Retrograde intrarenal surgery

    Arm Description

    All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.

    Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.

    Outcomes

    Primary Outcome Measures

    Stone free rate
    Stone-free conditions were determined by low-dose spiral CT taken in postoperative third month

    Secondary Outcome Measures

    Mean fluoroscopy time
    İntraoperative duration of flouroscopy time

    Full Information

    First Posted
    March 28, 2018
    Last Updated
    April 19, 2018
    Sponsor
    Abant Izzet Baysal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03503539
    Brief Title
    Are the Stone Density and Location Useful Parameters for Small Kidney Stones?
    Official Title
    Are the Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That Are Smaller Than 2 cm? Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Abant Izzet Baysal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm. The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Calculi, Kidney Stone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mini percutaneous nephrolithotomy
    Arm Type
    Experimental
    Arm Description
    All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.
    Arm Title
    Retrograde intrarenal surgery
    Arm Type
    Active Comparator
    Arm Description
    Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.
    Intervention Type
    Procedure
    Intervention Name(s)
    Mini percutaneous nephrolithotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Retrograde intrarenal surgery
    Primary Outcome Measure Information:
    Title
    Stone free rate
    Description
    Stone-free conditions were determined by low-dose spiral CT taken in postoperative third month
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Mean fluoroscopy time
    Description
    İntraoperative duration of flouroscopy time
    Time Frame
    İntraoperative duration of flouroscopy

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination. Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study. Exclusion Criteria: Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27706948
    Citation
    Demirbas A, Resorlu B, Sunay MM, Karakan T, Karagoz MA, Doluoglu OG. Which Should be Preferred for Moderate-Size Kidney Stones? Ultramini Percutaneous Nephrolithotomy or Retrograde Intrarenal Surgery? J Endourol. 2016 Dec;30(12):1285-1289. doi: 10.1089/end.2016.0370.
    Results Reference
    result
    PubMed Identifier
    24811281
    Citation
    Jacquemet B, Martin L, Pastori J, Bailly V, Guichard G, Bernardini S, Chabannes E, Bittard H, Kleinclauss F. Comparison of the efficacy and morbidity of flexible ureterorenoscopy for lower pole stones compared with other renal locations. J Endourol. 2014 Oct;28(10):1183-7. doi: 10.1089/end.2014.0286. Epub 2014 Sep 12.
    Results Reference
    result
    PubMed Identifier
    22840867
    Citation
    Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
    Results Reference
    result
    PubMed Identifier
    21855968
    Citation
    Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
    Results Reference
    result
    PubMed Identifier
    26318710
    Citation
    Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.
    Results Reference
    result
    PubMed Identifier
    22201298
    Citation
    Gucuk A, Uyeturk U, Ozturk U, Kemahli E, Yildiz M, Metin A. Does the Hounsfield unit value determined by computed tomography predict the outcome of percutaneous nephrolithotomy? J Endourol. 2012 Jul;26(7):792-6. doi: 10.1089/end.2011.0518. Epub 2012 Feb 10.
    Results Reference
    result

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