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

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

Patrocinadores

Patrocinador principal: Selcuk University

Fuente Selcuk University
Resumen breve

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.

Estado general Completed
Fecha de inicio June 2015
Fecha de Terminación March 2016
Fecha de finalización primaria March 2016
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Urine NGAL level (ng/mL) Within the first 7 days after surgery (RIRS)
Resultado secundario
Medida Periodo de tiempo
Blood urea level (mg/dL) and creatinine level (mg/dL) Within the first 7 days after surgery (RIRS)
Inscripción 60
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: RIRS with ureteral access sheath

Descripción: Ureteral access sheath will be used during RIRS.

Etiqueta de grupo de brazo: UAS (+)

Tipo de intervención: Device

Nombre de intervención: RIRS without ureteral access sheath

Descripción: Ureteral access sheath will not be used during RIRS.

Etiqueta de grupo de brazo: UAS (-)

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 65 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Ozcan Kilic, M.D. Principal Investigator Selcuk University, School of Medicine, Department of Urology
Ubicación
Instalaciones: Selcuk University, School of Medicine, Department of Urology
Ubicacion Paises

Turkey

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Selcuk University

Nombre completo del investigador: Ozcan Kilic

Título del investigador: Associate Professor, M.D.

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: UAS (+)

Tipo: Active Comparator

Descripción: 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).

Etiqueta: UAS (-)

Tipo: Experimental

Descripción: 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).

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov