Outcomes Comparison of Robotic, Retropubic, and Perineal... | NCT00442000

Studies
Outcomes Comparison of Robotic, Retropubic, and Perineal Prostatectomy

NCT00442000

Sponsor

Corewell Health East

Status

Completed

Last Update Posted

Mar 21, 2012Estimated

Enrollment

700Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Prostatectomy

Countries

United States

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

Mar 2012

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

Jan 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 28, 2007

First Submission Date that Met QC Criteria

Feb 28, 2007

First Posted Date

Mar 1, 2007Estimated

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

Mar 19, 2012

Last Update Posted Date

Mar 21, 2012Estimated

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

Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

Detailed Description

Existing data collected from Prostatectomy Database study and Urology Database study will be analyzed. Compare peri-operative and postoperative outcomes of the three different surgical approaches to prostatectomy

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

700Actual

Name	Type	Description	Arm Group Labels	Other Names
Prostatectomy	Procedure	Patients undergoing prostatectomy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age
Radical Prostatectomy at William Beaumont Hospital

Exclusion Criteria:

Dementia

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing prostatectomy at William Beaumont-Royal Oak.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Feber, M.D.	Corewell Health East	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011468	Prostatectomy

Ancestor Terms

ID	Term
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided