Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy

NCT ID: NCT00922818

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-05-26

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Radical perineal prostatectomy patients

Radical perineal prostatectomy patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 18 years of age
• Perineal prostatectomy for prostate cancer at Maimonides Medical Center

Exclusion Criteria

• Dementia

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason B. Wynberg, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Related Links

http://www.nlm.nih.gov/medlineplus/prostatecancer.html

Prostate Cancer Information

http://en.wikipedia.org/wiki/Perineum

Perineal Anatomy

Other Identifiers

09-05-VA02

Identifier Type: -

Identifier Source: org_study_id