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NCT Number: NCT02485002

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

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.

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Key information

Conditions

Urolithiasis Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University, School of Medicine, Department of Urology

Konya, 42075, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIRS with ureteral access sheath

Device

Ureteral access sheath will be used during RIRS.

RIRS without ureteral access sheath

Device

Ureteral access sheath will not be used during RIRS.

Primary outcomes

  1. Urine NGAL level (ng/mL)

    Time frame: 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 outcomes

  1. Blood urea level (mg/dL) and creatinine level (mg/dL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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