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临床试验/NCT01261871
NCT01261871已完成不适用

Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy

United States Naval Medical Center, San Diego1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Effect of radical prostatectomy technique on intraocular pressure.

研究概览

简要总结

The purpose of this study is to measure pressures within the eye (during surgery to remove the prostate or abdominopelvic masses) as the body position required for these laparoscopic procedures has been associated with increases in pressure within the eye.

详细描述

The National Cancer Institute estimates that 218,890 new cases of prostate cancer will have been diagnosed in 2007. The three most commonly chosen options for localized prostate cancer are radical prostatectomy (RP), external radiation therapy (XRT), and interstitial brachytherapy (BT). A variety of surgical approaches are available, including open, laparoscopic, and robotic prostatectomy. With the current trend towards "minimally invasive" techniques, laparoscopic prostatectomy (LP) and, in particular, robotic assisted LP are on the rise. Since gaining FDA approval in 2001, the robotic procedure has gained over 1/3 of the market share. Preliminary data suggests this number may now have grown to over 50% of all prostatectomies for cancer performed in the United States.

The minimally invasive procedures offer some advantages relative to the open alternative: smaller incisions, improved pain control, decreased blood loss, and faster recovery have been well documented. Cancer specific and quality of life (sexual function, continence) outcomes will need more long term evaluation before definitive advantages with the minimally invasive techniques are stated. Furthermore, there are potential risks with these minimally invasive methods that have not been fully elucidated.

During a laparoscopic or robotic prostatectomy, patients are subjected to a marked Trendelenberg position throughout the majority of the procedure. The effect of body positioning has been shown previously to affect intraocular pressure (IOP). However, the effect of surgical positioning on IOP during prostatectomies has not been well studied and is not definitively known. Anecdotal reports of postoperative vision loss following robotic assisted laparoscopic prostatectomy have surfaced thus further research is required to study the effect that these procedures for prostate cancer may have on IOP and vision.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Age ≥ 18 years
  • Patients choosing to undergo surgical treatment for prostate cancer

排除标准

  • Prior treatment of prostate cancer by any means
  • History of glaucoma, macular degeneration, or diabetic retinopathy
  • History of eye trauma/injury
  • History of non-refractive eye surgery
  • Allergy to topical anesthetic (this will be used during the eye exam)

结局指标

主要结局

Effect of radical prostatectomy technique on intraocular pressure.

时间窗: 30 days post surgical procedure.

次要结局

未报告次要终点

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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