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

Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607279
• Other study ID #: 2016-118
• Status: Completed
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: December 2018
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatectomy

Intervention

Procedure:
• NGAL

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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