Clinical trial NCT03614247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Renal Calculi
Keywords: Lower calyceal stone
cost-effectiveness
percutaneous nephrolithotomy
retrograde intrarenal surgery
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Turkey
First posted: 2018-08-03
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who had a lower calyceal stone between 1cm and 2cm in size
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stone free status
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Training and Research Hospital
name: Muhammet F Kilinc, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.