Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

Not Applicable

Completed

• Conditions: Renal Calculi
• Interventions: Procedure: Mini-PNL; Procedure: Retrograde intrarenal surgery; Procedure: Micro-PNL; Procedure: Ultra-mini PNL; Procedure: Standard PNL

• Registration Number: NCT03614247
• Lead Sponsor: Ankara Training and Research Hospital

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.

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-05-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini-PNL	Mini-PNL	Patients underwent mini percutaneous nephrolithotomy (tract size \<20 F) for lower calyceal stone between 1cm and 2cm in size
RIRS	Retrograde intrarenal surgery	Patients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size
Micro-PNL	Micro-PNL	Patients underwent micro percutaneous nephrolithotomy (tract size \<10 F) for lower calyceal stone between 1cm and 2cm in size
Ultramini-PNL	Ultra-mini PNL	Patients underwent ultra-mini percutaneous nephrolithotomy (tract size \<15 F) for lower calyceal stone between 1cm and 2cm in size
Standard PNL	Standard PNL	Patients underwent standard percutaneous nephrolithotomy (tract size \>25 F) for lower calyceal stone between 1cm and 2cm in size

Primary Outcome Measures

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