Differences in Urine NGAL Levels in Patients Undergoing RIRS With or Without Ureteral Access Sheath

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Device: RIRS without ureteral access sheath; Device: RIRS with ureteral access sheath

• Registration Number: NCT02485002
• Lead Sponsor: Selcuk University

Brief Summary

This study will include patients aged between 18 and 65 who will undergo retrograde infrarenal 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, neutrophil gelatinase-associated lipocalin (NGAL) (a more specific and early marker of kidney function) will be used to assess the differences in the kidney functions. Preoperative blood urea and creatinine levels and urine NGAL levels will be studied for all patients. After the surgery, blood urea and creatinine levels will be again studied as well as urine NGAL levels at postoperative 2nd hour, 72nd hour and 1st week.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Urine NGAL level (ng/mL)	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 urine NGAL level.

Secondary Outcome Measures

Name	Time	Method
Blood urea level (mg/dL) and 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 urea and creatinine levels.

Trial Locations

Locations (1)

Selcuk University, School of Medicine, Department of Urology; 🇹🇷 Konya, Turkey