Clinical trial NCT01261871: Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning
Official title: Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Hypertension
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2010-12-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing primary radical prostatectomy for the diagnosis of prostate cancer at Naval Medical Center San Diego.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Effect of radical prostatectomy technique on intraocular pressure.
timeFrame: 30 days post surgical procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: United States Naval Medical Center
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Brian K Auge, M.D.
role: PRINCIPAL_INVESTIGATOR
References: