Laparoendoscopic Single-site Radical Nephrectomy for Loca... | NCT00945984

Studies
Laparoendoscopic Single-site Radical Nephrectomy for Localized Renal Cell Carcinoma

NCT00945984

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jul 28, 2009Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Localized Renal Cell Carcinoma

Interventions

Radical nephrectomy

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 22, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

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 25, 2009

Last Update Posted Date

Jul 28, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.

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

Not provided

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LESS		Patients who underwent LESS radical nephrectomy	Procedure: Radical nephrectomy
Conventional laparoscopy		Patients who underwent conventional laparoscopic radical nephrectomy	Procedure: Radical nephrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radical nephrectomy	Procedure	Surgical options to treat localized renal cell carcinoma	Conventional laparoscopy LESS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical outcomes such as operative time, estimated blood loss		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with localized renal cell carcinoma

Exclusion Criteria:

Patients with lymph node or distant metastasis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Tertiary care center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyeon Hoe Kim, PhD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea