Trial record 6 of 304 for:
Open Studies | neoplasms "quality of life"
Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy
This study is not yet open for participant recruitment.
Verified June 2010 by Samsung Medical Center
Sponsor:
Samsung Medical Center
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
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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:
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) |
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 |
| Genders 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
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
No publications provided
| 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 |
| Health Authority: | South Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013