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

NCT ID: NCT03607279

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostatectomy

Keywords

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NGAL Prostatectomy Acute kidney injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NGAL - retropubic radical prostatectomy

Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia

NGAL

Intervention Type PROCEDURE

NGAL - robotic radical prostatectomy

Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia

NGAL

Intervention Type PROCEDURE

Interventions

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NGAL

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Arzu Karaveli

Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arzu Karaveli

Role: PRINCIPAL_INVESTIGATOR

Netherlands: Ministry of Health, Welfare and Sports

Locations

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Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25778333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26844486 (View on PubMed)

Other Identifiers

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2016-118

Identifier Type: -

Identifier Source: org_study_id