CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
RIRS with ureteral access sheath +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02485002
NCT02485002N/ACompleted

Differences in Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) Levels in Patients Undergoing Retrograde Intrarenal Surgery (RIRS) With or Without Ureteral Access Sheath (UAS)

Selcuk University·interventional·Posted Jun 30, 2015·Updated Nov 18, 2019

In Brief

A clinical study evaluating RIRS with ureteral access sheath and RIRS without ureteral access sheath for Urolithiasis. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrolithiasis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJun 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.0 years ago

Interventions

RIRS with ureteral access sheathdevice

Ureteral access sheath will be used during RIRS.

RIRS without ureteral access sheathdevice

Ureteral access sheath will not be used during RIRS.