## Protocol Section
### Identification Module
**NCT ID:** NCT03607279

**Brief Title:** Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels

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

#### Organization Study ID Info
**ID:** 2016-118
#### Organization
**Class:** OTHER_GOV
**Full Name:** Antalya Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2017-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-19

**Type:** ACTUAL

**Last Update Submit Date:** 2018-12-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-06

**Type:** ACTUAL

#### Start Date
**Date:** 2017-01

**Type:** ACTUAL

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2018-07-31
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-23
**Study First Submit QC Date:** 2018-07-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Antalya Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Antalya Training and Research Hospital

**Investigator Full Name:** Arzu Karaveli

**Investigator Title:** Study director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Prostatectomy

**Keywords:**

- NGAL

- Prostatectomy

- Acute kidney injury

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 66

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: NGAL

**Label:** NGAL - retropubic radical prostatectomy

#### Arm Group 2

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

**Intervention Names:**

- Procedure: NGAL

**Label:** NGAL - robotic radical prostatectomy

### Interventions

#### Intervention 1

**Arm Group Labels:**

- NGAL - retropubic radical prostatectomy

- NGAL - robotic radical prostatectomy

**Name:** NGAL

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Plasma NGAL was determined at baseline, 6 hours and 12 hours after surgery, ng/ml

**Measure:** Plasma NGAL

**Time Frame:** 0 hours, 6 hours and 12 hours after surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** prostatectomy

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Antalya

**Country:** Turkey

**Facility:** Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

**Zip:** 07100

#### Overall Officials

**Official 1:**

**Affiliation:** Netherlands: Ministry of Health, Welfare and Sports

**Name:** Arzu Karaveli

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 25778333

**Citation:** 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:** 26844486

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M28998

- Name: Acute Kidney Injury

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
