Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels

Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels After Robot-assisted Laparoscopic Versus Retropubic Radical Prostatectomy

The purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

Study Overview

• Status: Completed
• Conditions: Prostatectomy
• Intervention / Treatment: Procedure: NGAL

Detailed Description

Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI) because of intraoperative bleeding, obstructive uropathy and older age. In particular robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (RRP) is associated with postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI after urogenital oncosurgery.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

prostatectomy

Description

Inclusion Criteria:

• patients who undergo prostatectomy
• American Society of Anesthesiology (ASA) I-III

Exclusion Criteria:

• preexisting renal disease
• emergency surgery
• heart failure
• peripheral vascular disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NGAL - retropubic radical prostatectomy; Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia	Procedure: NGAL
NGAL - robotic radical prostatectomy; Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia	Procedure: NGAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma NGAL	Plasma NGAL was determined at baseline, 6 hours and 12 hours after surgery, ng/ml	0 hours, 6 hours and 12 hours after surgery

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Arzu Karaveli, Netherlands: Ministry of Health, Welfare and Sports

Publications and helpful links

General Publications

• Orsolya M, Attila-Zoltan M, Gherman V, Zaharie F, Bolboaca S, Chira C, Bodolea C, Tomuleasa C, Irimie A, Coman I, Ionescu D. The effect of anaesthetic management on neutrophil gelatinase associated lipocalin (NGAL) levels after robotic surgical oncology. J BUON. 2015 Jan-Feb;20(1):317-24.
• Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Acute kidney injury; Prostatectomy; NGAL
• Other Study ID Numbers: 2016-118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No