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临床试验/NCT00922818
NCT00922818撤回不适用

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy

Maimonides Medical Center1 个研究点 分布在 1 个国家开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Surgical margin-free rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Surgical margin-free rate

时间窗: June 2011

proportion of negative margins

次要结局

  • EPIC-26 Functional Outcome Status(June 2011)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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