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Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James

This study is currently recruiting participants.
Verified July 2012 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Ronney Abaza, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01643954
First received: May 8, 2012
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.


Condition Intervention
Prostate Cancer
 Procedure: robotic radical prostatectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Collect and analyze descriptive characteristics of patient population and summarize patient outcome data. [ Time Frame: up to 20 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlate the patient characteristics to the surgical outcomes. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • Determine the overall survival [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls. [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]
  • disease- free survival [ Time Frame: up to 20 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: September 2008
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm A
Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
Arm B
Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center .
 Procedure: robotic radical prostatectomy
robotic assisted surgery
Other Names:
  • laparoscopic surgery
  • The da Vinci system

Detailed Description:

This retrospective / prospective study will allow us to collect and analyze the presurgical, peri-operative, and outcome data of patients who undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center, beginning February 2008 onwards.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

ARM A:

Inclusion Criteria:

  • Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • 18 years and older

ARM B:

Inclusion Criteria:

  • Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • 18 years and older
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643954

Contacts
Contact: Ronney Abaza, MD 614-293-0981 ronney.abaza@osumc.edu

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Ronney Abaza, MD     614-293-0981     ronney.abaza@osumc.edu    
Principal Investigator: Ronney Abaza, MD            
Sponsors and Collaborators
Ronney Abaza
Investigators
Principal Investigator: Ronney Abaza, MD Ohio State Unversity
  More Information

Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ronney Abaza, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01643954     History of Changes
Other Study ID Numbers: OSU-08108
Study First Received: May 8, 2012
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
prostatectomy
surgery
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013