Use of Hypothermia During Robotic Prostatectomy

NCT ID: NCT00915031

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 738 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2015-06-30

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).

Detailed Description

2. 1. Selection of the Patients From June 2002 to August 2015, a total of 1,503 patients underwent RARP. During this period, perioperative data, including postoperative functional outcomes, were prospectively collected using a customized database; our ethics committee approved the data collection. Erectile function was assessed using the sexual health profile for men (SHIM) score at 3, 9, 15, and 24 months and then annually after surgery, and the duration of pad-free continence recovery was asked by a non-physician third party. In our institution, RH was applied during RARP for all patients from February 2008 to March 2015 (consecutively between the 671st and 1459th cases). Among the recruited patients, 789 men (52.6%) underwent HP, leaving the other 711 (47.4%) as controls.

The inclusion criteria for this study were as follows: (1) bilateral nerve-sparing RARP (over 70%) and (2) a minimum follow-up of 15 months. The exclusion criteria were as follows: (1) men with a history of salvage radiation therapy, chemotherapy, or hormone therapy after RARP (n=98) and (2) the presence of a high-risk disease with an initial prostate-specific antigen (PSA) level over 20 ng/ml or biopsy Gleason score over 8, which may influence the refining surgical plane around the neurovascular bundle (NVB), thereby affecting the degrees of nerve-sparing strategy at the time of surgery (n=275). Further, (3) the initial 100 cases were excluded to avoid potential bias from the learning period. From a cohort of 1,503 patients, 59 (3.92%) men whose potency outcome within 15 months was not assessed were also excluded from the study. Finally, 930 patients were selected for the analysis; half of the procedures (n=466, 50.1%) were performed under RH and the remaining other half (n=464, 49.9%) as normothermal controls.

2. 2. Endpoints of the Study The primary endpoints of this study were the SHIM score and the rate of potency regain, which was defined as a SHIM score >17 in the RH and control groups 15 months after surgery. Considering the proven impacts of age and preoperative SHIM scores on the recovery of potency, the groups were further divided into the young and potent (YP: age <65 years and SHIM score ≥22, n=409, 43.9%) subgroup and susceptible for impotency (SI: age ≥65 years or SHIM score <22, n=512, 55.1%) counterpart and investigated the sexual function of the YP subgroup. The secondary endpoints were the duration of pad-free continence regain and the rate of continence recovery within 3 months after surgery, especially in the YP subgroup.

2.3. Surgical Protocol for RH All procedures were performed by a single surgeon. RH was achieved by devising an endorectal cooling balloon system (ECB) as previously reported [2, 4, 5]. In brief, a 40-cm, 24-F, 3-way latex urethral catheter was placed inside a 5 × 2.5-inch elliptic latex balloon that distended at a low pressure and conformed to the rectal wall without excessive deformations. The lubricated ECB was inserted just inside the anus and anchored by inflating the catheter balloon to 20 ml. The ECB was then distended and cycled continuously with cold saline (4°C) by gravity 40 cm above the patient. The ECB volume was ~200 ml. A 9-F esophageal probe (Smiths Medical ASD, Rockland, MA) was used to obtain the intracorporeal temperature readings directly along the anterior surface of the rectum/NVB.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hypothermia Only OR

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

Group Type: ACTIVE_COMPARATOR

UroCool

Intervention Type: DEVICE

Hypothermia Endorectal Device

Hypothermia in OR + Recovery

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

Group Type: ACTIVE_COMPARATOR

UroCool

Intervention Type: DEVICE

Hypothermia Endorectal Device

Interventions

UroCool

Hypothermia Endorectal Device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• previous radiation
• previous cryotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Thomas E. Ahlering

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Ahlering, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

2008-6397

Identifier Type: -

Identifier Source: org_study_id