Urolithiasis
Conditions
Keywords
kidney stone, retrograde intrarenal surgery, ureteral access sheath, kidney function
Brief summary
In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the kidney functions by measuring blood and urine and Netrin-1 levels.
Detailed description
This study will include patients aged between 18 and 65 who will undergo retrograde intrarenal surgery (RIRS) due to renal stone(s). A total of 60 patients (male or female) will be recruited, and will be randomized into 2 groups consisting of 30 patients in each group. The first group of patients will undergo RIRS with a ureteral access sheath (UAS) positioned prior to surgery; and the second group will undergo RIRS without UAS. As use of UAS decreases the pressure in the renal pelvis during RIRS, it is aimed to evaluate whether using UAS or not affects the kidney functions. Besides the routine kidney function tests, namely urea and creatinine, and Netrin-1 (more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. Preoperative blood urea, creatinine and Netrin-1 levels and urine Netrin-1 levels will be studied for all patients. After the surgery, blood urea and creatinine levels will be again studied as well as blood Netrin-1 levels at postoperative 48th hour; and urine Netrin-1 levels at postoperative 24th hour.
Interventions
DEVICERIRS with UAS
Ureteral access sheath (UAS) will be used during RIRS.
DEVICERIRS without UAS
Ureteral access sheath will not be used during RIRS.
Sponsors
The Scientific and Technological Research Council of Turkey
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Being between 18-65 years old * Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone
Exclusion criteria
* Patients with uncontrolled diabetes mellitus and diabetic nephropathy * Patients with blood pressure \> 140/80 mmHg despite regular use of antihypertensive agent(s) * Patients with chronic kidney failure who need dialysis * Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier * Patients who have had pyelonephritis 3 months or much earlier * Patients younger than 18 years or older than 65 years * Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests * Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Netrin-1 level (pg/mL) | Within the first 48 hours after the surgery (RIRS) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood Netrin-1 level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Netrin-1 level (pg/mL) | Within the first 24 hours after the surgery (RIRS) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine Netrin-1 level. |
| Blood urea level (mg/dL) | Within the first 7 days after surgery (RIRS) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea levels. |
| Blood creatinine level (mg/dL) | Within the first 7 days after surgery (RIRS) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood creatinine levels. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOzcan Kilic, MD
Backup ContactMurat Akand, MD
Outcome results
None listed