Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261871
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
United States 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.

Condition or disease
Ocular Hypertension

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.

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy
Study Start Date : December 2008
Primary Completion Date : May 2010
Study Completion Date : May 2010

Robotic laparoscopic prostatectomy
Patients who are undergoing primary surgical treatment for a diagnosis of prostate operatively will be enrolled. IOP will be measured throughout the case to assess for change. The various techniques employed for a radical prostatectomy will be compared. Patients undergoing RRP (open surgery) will act as controls. Those undergoing LRP (minimally invasive surgery) will be compared with the control group to assess for differences in IOP that may result from the different approaches. three arms will be used for the comparison: open, laparoscopic intraperitoneal approach), and laparoscopic (extraperitoneal approach).

Primary Outcome Measures :
  1. Effect of radical prostatectomy technique on intraocular pressure. [ Time Frame: 30 days post surgical procedure. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01261871

United States, California
United States Naval Medical Center
San Diego, California, United States, 92134-5000
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Principal Investigator: Brian K Auge, M.D. United States Naval Medical Center, San Diego

Responsible Party: United States Naval Medical Center, San Diego Identifier: NCT01261871     History of Changes
Other Study ID Numbers: NMCSD.2008.0045
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases