Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01261871
First received: December 15, 2010
Last updated: December 16, 2010
Last verified: December 2009
  Purpose

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
Ocular Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Effect of radical prostatectomy technique on intraocular pressure. [ Time Frame: 30 days post surgical procedure. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Robotic laparoscopic prostatectomy

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

Ages Eligible for Study:   18 Years and older
Genders 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.

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261871

Locations
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
Investigators
Principal Investigator: Brian K Auge, M.D. United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: Brian K. Auge/ Principal Investigator, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01261871     History of Changes
Other Study ID Numbers: NMCSD.2008.0045
Study First Received: December 15, 2010
Last Updated: December 16, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014