Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy
Status: | Withdrawn |
---|---|
Conditions: | Prostate Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/22/2018 |
Start Date: | June 2009 |
End Date: | May 26, 2011 |
Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy
Our objective is to evaluate the clinical outcomes for the anatomic radical perineal
prostatectomy (RPP) for the surgical management of prostate cancer. We will report the
perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal
prostatectomy at our institution.
prostatectomy (RPP) for the surgical management of prostate cancer. We will report the
perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal
prostatectomy at our institution.
The purpose of our study is to evaluate perioperative, oncologic, and functional outcomes for
the anatomic radical perineal prostatectomy. The anatomic radical perineal prostatectomy is
standard-of-care surgical approach to the surgical management of localized prostate cancer.
The operative technique selected for radical prostatectomy is largely based on patient
preference after appropriate counseling, and surgeon recommendation based on surgical
considerations and surgeon experience. Outcome data for the anatomic radical perineal
prostatectomy will represent a valuable addition to the published body of literature. Our
study is a prospective clinical outcome data collection and analysis and we will be looking
at data within several domains. First, perioperative data will be collected to evaluate the
OR time, blood loss, surgical complications, and length of hospital stay for the anatomic
radical perineal prostatectomy. Second, oncologic efficacy of this procedure will be
reported, based on margin status of surgical specimens, which will be correlated with tumor
features (Gleason score, tumor volume, pre-op PSA score). Third, functional outcomes will be
evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op
settings. This third domain will be accomplished by employing the following validated
questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be filled out
at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.
the anatomic radical perineal prostatectomy. The anatomic radical perineal prostatectomy is
standard-of-care surgical approach to the surgical management of localized prostate cancer.
The operative technique selected for radical prostatectomy is largely based on patient
preference after appropriate counseling, and surgeon recommendation based on surgical
considerations and surgeon experience. Outcome data for the anatomic radical perineal
prostatectomy will represent a valuable addition to the published body of literature. Our
study is a prospective clinical outcome data collection and analysis and we will be looking
at data within several domains. First, perioperative data will be collected to evaluate the
OR time, blood loss, surgical complications, and length of hospital stay for the anatomic
radical perineal prostatectomy. Second, oncologic efficacy of this procedure will be
reported, based on margin status of surgical specimens, which will be correlated with tumor
features (Gleason score, tumor volume, pre-op PSA score). Third, functional outcomes will be
evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op
settings. This third domain will be accomplished by employing the following validated
questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be filled out
at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.
Inclusion Criteria:
- 18 years of age
- Perineal prostatectomy for prostate cancer at Maimonides Medical Center
Exclusion Criteria:
- Dementia
We found this trial at
1
site
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
Click here to add this to my saved trials