Use of Hypothermia During Robotic Prostatectomy

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: 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
Information provided by (Responsible Party):
Victor Huynh, University of California, Irvine

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hypothermic Nerve Sparing Radical Prostatectomy
Study Start Date : August 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Hypothermia Only OR
Use of Hypothermia Cooling device only in the operating room
Device: UroCool
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.
Device: UroCool
Hypothermia Endorectal Device

Primary Outcome Measures :
  1. 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 ]

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

Inclusion Criteria:

  • adult males
  • receiving robotic radical prostatectomy for the treatment of prostate cancer

Exclusion Criteria:

  • previous radiation
  • previous cryotherapy

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): NCT00915031

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Principal Investigator: Thomas Ahlering, MD University of California, Irvine

Responsible Party: Victor Huynh, Urology Account Contact, University of California, Irvine Identifier: NCT00915031     History of Changes
Other Study ID Numbers: 2008-6397
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Victor Huynh, University of California, Irvine:
Robotic prostatectomy

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms