Cost-Effectiveness of Different Treatment Options for Lower Calyceal Stones
1 other identifier
interventional
175
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 30, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedAugust 3, 2018
July 1, 2018
11 years
July 30, 2018
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone free status
Stone-free was defined as no rest stone or ≤ 3mm clinical insignificance rest stone
3 months
Study Arms (5)
RIRS
ACTIVE COMPARATORPatients underwent retrograde intrarenal surgery for lower calyceal stone between 1cm and 2cm in size
Micro-PNL
ACTIVE COMPARATORPatients underwent micro percutaneous nephrolithotomy (tract size \<10 F) for lower calyceal stone between 1cm and 2cm in size
Ultramini-PNL
ACTIVE COMPARATORPatients underwent ultra-mini percutaneous nephrolithotomy (tract size \<15 F) for lower calyceal stone between 1cm and 2cm in size
Mini-PNL
ACTIVE COMPARATORPatients underwent mini percutaneous nephrolithotomy (tract size \<20 F) for lower calyceal stone between 1cm and 2cm in size
Standard PNL
ACTIVE COMPARATORPatients underwent standard percutaneous nephrolithotomy (tract size \>25 F) for lower calyceal stone between 1cm and 2cm in size
Interventions
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.
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- Patients who had a lower calyceal stone between 1cm and 2 cm in size
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ankara Training and Research Hospitallead
- Ministry of Health, Turkeycollaborator
Related Publications (3)
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.
PMID: 25614255RESULTSabnis 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.
PMID: 23826843RESULTDemirbas 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.
PMID: 27706948RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammet F Kilinc, M.D.
Ankara Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 30, 2018
First Posted
August 3, 2018
Study Start
January 1, 2007
Primary Completion
January 1, 2018
Study Completion
May 1, 2018
Last Updated
August 3, 2018
Record last verified: 2018-07