Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery

Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.

Study Overview

• Status: Completed
• Conditions: the Patients With Partial Nephrectomy

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. the adult patients with open partial nephrectomy
2. the adult patients with laparoscopic partial nephrectomy
3. the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy

Description

Inclusion Criteria:

1. adults patient more than 20 years old with ASA score 1-3
2. the patients who undergoing partial nephrectomy for the renal mass less than 7 cm

Exclusion Criteria:

1. the patient with previous history with renal surgery
2. the patient with bilateral partial nephrectomy
3. the patient with synchronous operation for other intraperitoneal surgery
4. the renal mass more than 7 cm
5. previous kinds of surgery is changed into other kinds due to bleeding, etc
6. the patient with serum Cr level more than 1.4 mg/dl
7. the patient who does not understand the consent form

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
the patients with open partial nephrectomy; the adult patients with open partial nephrectomy
laparoscopic; the adult patients with laparoscopic partial nephrectomy
VAMS; the adult patients with VAMS partial nephrectomy
robotic; the adult patients with robotic partial nephrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of urinary NGAL	Analysis of correlation between the level of preoperative and postoperative urinary NGAL	changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): July 2, 2013

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: acute kidney injury, partial nephrectomy, biomarker
• Other Study ID Numbers: 4-2013-0261