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:

Information provided by:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01173952

First received: July 30, 2010

Last updated: NA

Last verified: June 2010

History: No changes posted

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


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 30, 2010
Last Updated:	July 30, 2010

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 July 21, 2017

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