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

NCT02485002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-18

No results posted yet for this study

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.

Conditions

  • Urolithiasis

Interventions

DEVICE

RIRS with ureteral access sheath

Ureteral access sheath will be used during RIRS.

DEVICE

RIRS without ureteral access sheath

Ureteral access sheath will not be used during RIRS.

Sponsors & Collaborators

  • Selcuk University

    lead OTHER

Principal Investigators

  • Ozcan Kilic, M.D. · Selcuk University, School of Medicine, Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485002 on ClinicalTrials.gov