Use of Hypothermia During Robotic Prostatectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Victor Huynh, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00915031
First received: June 3, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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).

References

  1. Khan F, Rodriguez E, Finley DS, Skarecky DW, Ahlering TE. Spread of thermal energy and heat sinks: implications for nerve-sparing robotic prostatectomy. J Endourol. 2007 Oct;21(10):1195-8.
  2. Weld KJ, Koziol S, Montiglio C, Sorenson P, Cespedes RD, Bishoff JT. Feasibility of laparoscopic renal cooling with near-freezing saline irrigation delivered with a standard irrigator aspirator. Urology. 2007 Mar;69(3):465-8
  3. Gill IS, Abreu SC, Desai MM, Steinberg AP, Ramani AP, Ng C, Banks K, Novick AC, Kaouk JH.

    Laparoscopic ice slush renal hypothermia for partial nephrectomy: the initial experience.

    J Urol. 2003 Jul;170(1):52-6.

  4. Wakabayashi Y, Narita M, Kim CJ, Kawakami T, Yoshiki T, Okada Y. Renal hypothermia using ice slush for retroperitoneal laparoscopic partial nephrectomy. Urology. 2004 Apr;63(4):773-5.
  5. Wagner KR, Zuccarello M. Local brain hypothermia for neuroprotection in stroke treatment and aneurysm repair. Neurol Res. 2005 Apr;27(3):238-45
  6. Iwata O, Thornton JS, Sellwood MW, Iwata S, Sakata Y, Noone MA, O'Brien FE, Bainbridge A, De Vita E, Raivich G, Peebles D, Scaravilli F, Cady EB, Ordidge R, Wyatt JS, Robertson NJ . Depth of delayed cooling alters neuroprotection pattern after hypoxia-ischemia. . Ann Neurol. 2005 Jul;58(1):75-87
  7. Zhao H, Wang JQ, Shimohata T, Sun G, Yenari MA, Sapolsky RM, Steinberg GK.Conditions of protection by hypothermia and effects on apoptotic pathways in a rat model of permanent middle cerebral artery occlusion. J Neurosurg. 2007 Sep;107(3):636-41.
  8. Ridenour TR, Warner DS, Todd MM, McAllister AC. Mild hypothermia reduces infarct size resulting from temporary but not permanent focal ischemia in rats. Stroke. 1992 May;23(5):733-8.
  9. Sahuquillo J, Vilalta A. Cooling the injured brain: how does moderate hypothermia influence the pathophysiology of traumatic brain injury. Curr Pharm Des. 2007;13(22):2310-22

Condition Intervention
Prostate Cancer
Device: UroCool

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hypothermic Nerve Sparing Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous radiation
  • previous cryotherapy
  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: NCT00915031

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

No publications provided

Responsible Party: Victor Huynh, Urology Account Contact, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00915031     History of Changes
Other Study ID Numbers: 2008-6397
Study First Received: June 3, 2009
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Robotic prostatectomy
Hypothermia
Potency

Additional relevant MeSH terms:
Hypothermia
Prostatic Neoplasms
Body Temperature Changes
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014