Ocular HypertensionNCT01261871
Intraocular Pressure During Robotic Assisted Laparoscopic Procedures Utilizing Steep Trendelenburg Positioning
An observational study of Ocular Hypertension, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ocular Hypertension
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are undergoing primary radical prostatectomy for the diagnosis of prostate cancer at Naval Medical Center San Diego.
Who may be able to join
- Age ≥ 18 years
- Patients choosing to undergo surgical treatment for prostate cancer
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Naval Medical Center
San Diego, California, 92134-5000
About this study
Official title: Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy
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.
Read the 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.
- Conditions
- Ocular Hypertension
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of radical prostatectomy technique on intraocular pressure.
Measured: 30 days post surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Brian K Auge, M.D., Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261871
- Sponsor's protocol ID
- NMCSD.2008.0045
- Status last verified
- Aug 2016
- First submitted
- 15 Dec 2010
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure During Robotic Prostatectomy, Laparoscopic Surgery, and Open Exploratory Laparotomy
- ClinicalTrials.gov ID
- NCT01261871
- Acronym / sponsor ID
- NMCSD.2008.0045
- Conditions
- Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are undergoing primary radical prostatectomy for the diagnosis of prostate cancer at Naval Medical Center San Diego.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patients choosing to undergo surgical treatment for prostate cancer
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of radical prostatectomy technique on intraocular pressure.
Time frame: 30 days post surgical procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian K Auge, M.D. principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Hypertension, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of radical prostatectomy technique on intraocular pressure. (time frame: 30 days post surgical procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.