Use of Hypothermia During Robotic Prostatectomy

NCT00915031 | Completed Results DMC

• 1 other identifier: 2008-6397
• Study Type: interventional
• Target: 738
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Robotic prostatectomy; Hypothermia; Potency

Outcome Measures

Primary Outcomes (1)

• Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence

  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. Continence is defined as no protective urinary pad use as reported by the patient in response to the very first question on page 1 of the sample questionnaire.

  During and 6 hours post surgery

Study Arms (2)

Hypothermia Only OR

ACTIVE COMPARATOR

Use of Hypothermia Cooling device only in the operating room. Intervention is Hypothermia Cooling Device.

Device: UroCool

Hypothermia in OR + Recovery

ACTIVE COMPARATOR

Use of hypothermia cooling device in the operating room and up to five hours after surgery is intervention.

Device: UroCool

Interventions

UroCool DEVICE

Hypothermia Endorectal Device

Hypothermia Only OR; Hypothermia in OR + Recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous radiation
• previous cryotherapy

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Hypothermia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Linda Huynh
• Organization: University of California, Irvine

lindamh@uci.edu

7144567354

Study Officials

• Thomas Ahlering, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 27, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Locations

US (1)