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Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173952
First Posted: August 2, 2010
Last Update Posted: August 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Samsung Medical Center
  Purpose
This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Condition
Prostatic Neoplasms Quality of Life

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:
Estimated Enrollment: 350
Study Start Date: August 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function

At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.

All will be enrolled at Samsung Medical Center

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with prostate cancer
Criteria

Inclusion Criteria:

  • Pathologic diagnosis of prostate adenocarcinoma
  • Clinical stage: AJCC (VI) stage T1-T2 N0M0
  • Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy

Exclusion Criteria:

  • Clinical Stage: T3, T4, nodal or distant metastasis
  • All kind of neoadjuvant, concurrent and adjuvant treatment
  • poor health forced a patient into dropout
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173952


Contacts
Contact: Sung Won Lee, M.D.& Ph.D. 82-2-3410-3552 drswlee@skku.edu
Contact: Deok Hyun Han, M.D.& Ph.D. 82-2-3410-6431 deokhyun.han@samsung.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Chair: Sung Won Lee, M.D.& Ph.D. Department of Urology Samsung Medical Center
  More Information

Responsible Party: Sung Won Lee, M.D.& Ph.D./Professor, Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Urology Samsung Medical Center, Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT01173952     History of Changes
Other Study ID Numbers: 2010-06-026
First Submitted: July 30, 2010
First Posted: August 2, 2010
Last Update Posted: August 2, 2010
Last Verified: June 2010

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


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