Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones

Ankara Training and Research Hospital

Status: Completed

Conditions: Renal Calculi

Treatments: Procedure: Standard PNL; Procedure: Micro-PNL; Procedure: Mini-PNL; Procedure: Ultra-mini PNL; Procedure: Retrograde intrarenal surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03614247

2730

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 5 patient groups

RIRS

Active Comparator group

Description:

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

Treatment:

Procedure: Retrograde intrarenal surgery

Micro-PNL

Active Comparator group

Description:

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

Treatment:

Procedure: Micro-PNL

Ultramini-PNL

Active Comparator group

Description:

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

Treatment:

Procedure: Ultra-mini PNL

Mini-PNL

Active Comparator group

Description:

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

Treatment:

Procedure: Mini-PNL

Standard PNL

Active Comparator group

Description:

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

Treatment:

Procedure: Standard PNL