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

NCT ID: NCT01173952

Last Updated: 2010-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Prostatic Neoplasms Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Department of Urology Samsung Medical Center, Sungkyunkwan University School of Medicine

Principal Investigators

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Sung Won Lee, M.D.& Ph.D.

Role: STUDY_CHAIR

Department of Urology Samsung Medical Center

Central Contacts

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Sung Won Lee, M.D.& Ph.D.

Role: CONTACT

82-2-3410-3552

Deok Hyun Han, M.D.& Ph.D.

Role: CONTACT

82-2-3410-6431

Other Identifiers

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2010-06-026

Identifier Type: -

Identifier Source: org_study_id

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