Are the Stone Density and Location Useful Parameters That Can Determine the Endourological Surgical Technique for Kidney Stones That Are Smaller Than 2 cm? Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- Stone free rate
Study Overview
Brief Summary
The investigators aimed to evaluate whether these parameters could be guides for us in the selection of RIRS or Mini-PNL procedures in kidney stones that are smaller than 2 cm.
The patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. RIRS was performed in the RIRS group using a 7.5-F fiberoptic flexible ureterorenoscope while Mini-PCNL group was dilated up to 16.5F and mini-PCNL was performed with 12F nephroscopy. Preoperative characteristics, operative and postoperative results were compared in two groups. Thereafter, intra and intergroup comparisons were made to determine the effects of HU value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients were evaluated with non-contrast abdominopelvic CT after a detailed anamnesis and physical examination.
- •Patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo ESWL, were taken into the study.
Exclusion Criteria
- •Patients with anomalous kidneys, skeletal deformities, severe obesity (BMI> 35) and those underwent ESWL treatment previously for the same stone were excluded from the study.
Arms & Interventions
Mini percutaneous nephrolithotomy
All operations were performed or supervised by the same surgeon. Right after the patients in mini-PNL group were placed a 5F ureteral catheter with general anesthesia, they were had a prone position and the access was performed by choosing the optimal calyx to reach the stone following the contrast agent was given. The guide wire was then placed and the stones were broken with a laser lithotripter using a 12F nephroscope (Modular minimally invasive PCNL system, Karl Storz, Tuttlingen, Germany) following the dilatation using an one step dilator with a 16.5F access sheath. When necessary, stones were removed using the stone removal forceps. Right after a 14-Fr nephrostomy tube was inserted and an antegrade pyelography was taken, the operation was terminated.
Intervention: Mini percutaneous nephrolithotomy (Procedure)
Retrograde intrarenal surgery
Following the general anesthesia performed, a safety guide wire was placed and semirigid ureteroscopy (9.5 / 11.5F) was performed. Stones were fragmented using a 270 micron meter laser fiber with the help of 7.5-F fiber optic flexible ureterorenoscope after the placement of ureteral access sheat (9.5 / 11.5 F). Stone fragmentation was accomplished using a laser energy of 0.5-1.5 J and a rate of 5-15 Hz and adjusting this range according to stone hardness. 4.7F JJ stent was routinely placed at the end of the operation because of worries about possible edema etc. due to access sheath. In this group, access sheath could not be placed in 2 patients due to the small diameter of the ureter, and JJ stent was placed, and 2 weeks later, the procedure was performed as it was in the others.
Intervention: Retrograde intrarenal surgery (Procedure)
Outcomes
Primary Outcomes
Stone free rate
Time Frame: 1 year
Stone-free conditions were determined by low-dose spiral CT taken in postoperative third month
Secondary Outcomes
- Mean fluoroscopy time(İntraoperative duration of flouroscopy)
Investigators
Adnan Gucuk
Associate Professor
Abant Izzet Baysal University