Use of Hypothermia During Robotic Prostatectomy
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|ClinicalTrials.gov Identifier: NCT00915031|
Recruitment Status : Unknown
Verified June 2013 by Victor Huynh, University of California, Irvine.
Recruitment status was: Enrolling by invitation
First Posted : June 5, 2009
Last Update Posted : June 26, 2013
Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number of men: incontinence and erectile function.
Urinary continence and erectile function
It is commonly believed that the most important factor affecting continence is preservation of the external urinary sphincter complex which lies just below the prostate. Trauma to the urethral tissue itself after it is transected from the prostate and damage to the autonomic nerves that control this sphincter may lead to sphincteric dysfunction. In addition, dissection of the bladder may lead to bladder irritability which also plays a role in incontinence. Surgical removal of the prostate also causes significant inflammatory damage to the pelvic floor which likely delays recovery of urinary continence. The same trauma issues apply to sexual function.
One possible method to protect the nerves and other tissues from operative trauma may be the use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice, ice slush, or cold irrigation has been safely and routinely used for decades in humans during brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: UroCool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypothermic Nerve Sparing Radical Prostatectomy|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||January 2015|
Active Comparator: Hypothermia Only OR
Use of Hypothermia Cooling device only in the operating room
Hypothermia Endorectal Device
Active Comparator: Hypothermia in OR + Recovery
Use of hypothermia cooling device in the operating room and up to five hours after surgery.
Hypothermia Endorectal Device
- The primary aim is confirmation of the feasibility and safety using an improved, more efficient and less labor intensive cooling balloon in patients undergoing hypothermic nerve-sparing RLP. [ Time Frame: During and 6 hours post surgery ]
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 ClinicalTrials.gov identifier (NCT number): NCT00915031
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Thomas Ahlering, MD||University of California, Irvine|