NCT03607279

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

July 23, 2018

Last Update Submit

December 18, 2018

Conditions

Keywords

NGALProstatectomyAcute kidney injury

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

Procedure: NGAL

NGAL - robotic radical prostatectomy

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

Procedure: NGAL

Interventions

NGALPROCEDURE
NGAL - retropubic radical prostatectomyNGAL - robotic radical prostatectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

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: 25778333BACKGROUND
  • 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.

    PMID: 26844486BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Arzu Karaveli

    Netherlands: Ministry of Health, Welfare and Sports

    PRINCIPAL INVESTIGATOR

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

Locations