Assessment of Acute Renal Injury During Partial Nephrecto... | NCT01891032

Studies
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

NCT01891032

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

160Actual

Phase

Not provided

Conditions

the Patients With Partial Nephrectomy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Apr 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jun 27, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jul 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the adult patients with open partial nephrectomy
the adult patients with laparoscopic partial nephrectomy
the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine		Seoul	Seoul	120-752	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases