Use of Hypothermia During Robotic Prostatectomy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Hospital |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/29/2019 |
| Start Date: | August 2009 |
| End Date: | June 2015 |
Hypothermic Nerve Sparing Radical Prostatectomy
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).
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).
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.
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.
Inclusion Criteria:
- adult males
- receiving robotic radical prostatectomy for the treatment of prostate cancer
Exclusion Criteria:
- previous radiation
- previous cryotherapy
We found this trial at
1
site
101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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