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NCT01173952 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01173952
Other study ID # 2010-06-026
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 30, 2010
Last updated July 30, 2010
Start date August 2010
Est. completion date January 2014

Study information
Verified date June 2010
Source Samsung Medical Center
Contact Sung Won Lee, M.D.& Ph.D.
Phone 82-2-3410-3552
Email drswlee@skku.edu
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 350
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center
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