Know Cancer

or
forgot password

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy


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.


Inclusion Criteria:



- 18 years of age

- Perineal prostatectomy for prostate cancer at Maimonides Medical Center

Exclusion Criteria:

- Dementia

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Surgical margin-free rate

Outcome Time Frame:

June 2011

Safety Issue:

No

Principal Investigator

Jason B. Wynberg, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maimonides Medical Center

Authority:

United States: Institutional Review Board

Study ID:

09-05-VA02

NCT ID:

NCT00922818

Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Prostate Cancer
  • Perineal
  • Prostatectomy
  • Nerve
  • Anatomic
  • Surgery
  • Neoplasms, Prostatic
  • Prostate Cancer
  • Prostate Neoplasms
  • Prostatic Cancer
  • Prostate
  • Cancer
  • Recurrent
  • Prostatic Neoplasms

Name

Location

Maimonides Medical CenterBrooklyn, New York  11219