Effect of Use of Ureteral Access Sheath on Levels of Netrin-1 in Patients Undergoing RIRS

Selcuk University

Status: Unknown

Conditions: Urolithiasis

Treatments: Device: RIRS without UAS; Device: RIRS with UAS

Study type: Interventional

Funder types: Other

Identifiers

NCT02533414

SU-RIRS-UAS-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

UAS (+)

Experimental group

Description:

RIRS with UAS: A ureteral access sheath (UAS) will be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Treatment:

Device: RIRS with UAS

UAS (-)

Active Comparator group

Description:

RIRS without UAS: A ureteral access sheath (UAS) will not be positioned into the ureter of the patient prior to the insertion of the flexible ureterorenoscope (RIRS).

Treatment:

Device: RIRS without UAS