Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels
1 other identifier
observational
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedDecember 19, 2018
December 1, 2018
5 months
July 23, 2018
December 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
NGAL - retropubic radical prostatectomy
Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia
NGAL - robotic radical prostatectomy
Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia
Interventions
Eligibility Criteria
prostatectomy
You may qualify if:
- patients who undergo prostatectomy
- American Society of Anesthesiology (ASA) I-III
You may not qualify if:
- preexisting renal disease
- emergency surgery
- heart failure
- peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 25778333BACKGROUNDJoo 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.
PMID: 26844486BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arzu Karaveli
Netherlands: Ministry of Health, Welfare and Sports
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study director
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 31, 2018
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
December 19, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share