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Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

Primary Purpose

Renal Calculi

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Retrograde intrarenal surgery
Micro-PNL
Ultra-mini PNL
Mini-PNL
Standard PNL
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculi focused on measuring Lower calyceal stone, cost-effectiveness, percutaneous nephrolithotomy, retrograde intrarenal surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had a lower calyceal stone between 1cm and 2 cm in size

Exclusion Criteria:

  • solitary or anomaly (horseshoe or pelvic kidney) kidney,
  • renal insufficiency,
  • pregnancy,
  • patient younger than 18 or older than 75 years,
  • non-interrupted antithrombotic medication before surgery,
  • urinary tract infection,
  • double-j or nephrostomy insertion before surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    RIRS

    Micro-PNL

    Ultramini-PNL

    Mini-PNL

    Standard PNL

    Arm Description

    Patients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size

    Patients underwent micro percutaneous nephrolithotomy (tract size <10 F) for lower calyceal stone between 1cm and 2cm in size

    Patients underwent ultra-mini percutaneous nephrolithotomy (tract size <15 F) for lower calyceal stone between 1cm and 2cm in size

    Patients underwent mini percutaneous nephrolithotomy (tract size <20 F) for lower calyceal stone between 1cm and 2cm in size

    Patients underwent standard percutaneous nephrolithotomy (tract size >25 F) for lower calyceal stone between 1cm and 2cm in size

    Outcomes

    Primary Outcome Measures

    Stone free status
    Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2018
    Last Updated
    July 30, 2018
    Sponsor
    Ankara Training and Research Hospital
    Collaborators
    Ministry of Health, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03614247
    Brief Title
    Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones
    Official Title
    Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones of 1 to 2 Centimeters: A Prospective, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2007 (Actual)
    Primary Completion Date
    January 1, 2018 (Actual)
    Study Completion Date
    May 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Training and Research Hospital
    Collaborators
    Ministry of Health, Turkey

    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 aim of the present study to perform a full cost analysis for the complete clearance of calyceal stones by retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PNL) for the treatment of lower calyceal stones between 1 and 2 centimeters (cm) in size.
    Detailed Description
    The lifelong prevalence of urinary system stone disease is approximately 15%. The lower calyx is the most common location where renal calculi occur. Because anatomical factors preclude spontaneous passage in this area, the need for treatment is more likely in lower calyceal stones. The European Association of Urology (EAU) suggests percutaneous nephrolithotomy (PNL) for stones larger than 2 centimeters (cm) and shock wave lithotripsy (SWL) or retrograde intrarenal surgery (RIRS) for stones smaller than 1cm as a first option, but controversy continues regarding the best treatment option for medium-sized lower calyceal stones of between 1cm and 2cm. Medical costs are divided into two components: direct and indirect. Direct costs encompass all medical expenditures (e.g., drugs, hospital bed, all consumable and non-consumable materials used during the operation), while indirect costs include loss of working days for the patient. The stone-free rates (SFR) are reported as approximately 60% and 90% for one session of RIRS and PNL, respectively; however, no physician can guarantee a 100% SFR for one session. For this reason, a full cost analysis must include the direct and indirect costs of both the first and all auxiliary procedures. The aim of this study was to perform a full cost analysis for the complete clearance of calyceal stones by RIRS and all PNL types for the treatment of lower calyceal stones between 1cm and 2cm in size.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Calculi
    Keywords
    Lower calyceal stone, cost-effectiveness, percutaneous nephrolithotomy, retrograde intrarenal surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who had a lower calyceal stone between 1cm and 2cm in size
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    175 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RIRS
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size
    Arm Title
    Micro-PNL
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent micro percutaneous nephrolithotomy (tract size <10 F) for lower calyceal stone between 1cm and 2cm in size
    Arm Title
    Ultramini-PNL
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent ultra-mini percutaneous nephrolithotomy (tract size <15 F) for lower calyceal stone between 1cm and 2cm in size
    Arm Title
    Mini-PNL
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent mini percutaneous nephrolithotomy (tract size <20 F) for lower calyceal stone between 1cm and 2cm in size
    Arm Title
    Standard PNL
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent standard percutaneous nephrolithotomy (tract size >25 F) for lower calyceal stone between 1cm and 2cm in size
    Intervention Type
    Procedure
    Intervention Name(s)
    Retrograde intrarenal surgery
    Intervention Description
    The procedure was performed with the patient in the dorsal lithotomy position under general anesthesia. Firstly, diagnostic ureteroscopy was done with a 6/7.5 Fr semi-rigid ureteroscope (Richard Wolf, Knittlingen, Germany). A 0.035mm double-tipped sensor guidewire was placed to the renal pelvis. A 10/12 Fr ureteric access sheath (Cook Medical, Indiana, USA) was used. A 7.5 Fr flexible ureteroscope (Flex X2, Karl Storz, Tuttlingen, Germany) was used for the main procedure. The stones were fragmented using a Holmium:Yttrium Aluminum Garnet laser (272 microns). At the end of each procedure, a double-j ureteric catheter and urethral catheter were routinely placed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Micro-PNL
    Intervention Description
    The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 4.8 Fr for micro PNL (PolyDiagnost, Pfaffenhofen, Germany). Stone fragmentation was carried out using laser in micro PNL. No nephrostomy was placed in any patient whom underwent micro PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultra-mini PNL
    Intervention Description
    The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 7.5 Fr for ultramini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using laser in ultramini PNL. No nephrostomy was placed in any patient whom underwent ultramini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Mini-PNL
    Intervention Description
    The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 12 Fr for mini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in mini PNL. No nephrostomy was placed in any patient whom underwent mini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard PNL
    Intervention Description
    The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 24 Fr for standard PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in standard PNL. A nephrostomy was placed in all standard PNL patients at the end of the procedure
    Primary Outcome Measure Information:
    Title
    Stone free status
    Description
    Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who had a lower calyceal stone between 1cm and 2 cm in size Exclusion Criteria: solitary or anomaly (horseshoe or pelvic kidney) kidney, renal insufficiency, pregnancy, patient younger than 18 or older than 75 years, non-interrupted antithrombotic medication before surgery, urinary tract infection, double-j or nephrostomy insertion before surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhammet F Kilinc, M.D.
    Organizational Affiliation
    Ankara Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25614255
    Citation
    Schoenthaler M, Wilhelm K, Hein S, Adams F, Schlager D, Wetterauer U, Hawizy A, Bourdoumis A, Desai J, Miernik A. Ultra-mini PCNL versus flexible ureteroscopy: a matched analysis of treatment costs (endoscopes and disposables) in patients with renal stones 10-20 mm. World J Urol. 2015 Oct;33(10):1601-5. doi: 10.1007/s00345-015-1489-4. Epub 2015 Jan 23.
    Results Reference
    result
    PubMed Identifier
    23826843
    Citation
    Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
    Results Reference
    result
    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

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    Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

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