The Impact of Low Pressure Pneumo in RARP
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 12/14/2017 |
| Start Date: | October 17, 2017 |
| End Date: | April 1, 2021 |
| Contact: | Jaschar Shakuri-Rad, DO |
| Email: | jaschar.shakuri-rad@metrogr.org |
| Phone: | 616-252-5026 |
The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate clinical significance of low pressure
pneumoperitoneum during robotically assisted radical prostatectomy (RARP).
pneumoperitoneum during robotically assisted radical prostatectomy (RARP).
Laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical
specialties. However, the use of pneumoperitoneum comes with known risks given the change in
physiological parameters that accompany its utilization. The effects of increased
intra-abdominal pressure on cardiopulmonary function has been well documented. Increased
pressure on the large vessels may lead to decreased cardiac output and thereby decreased
blood flow to various organ systems and cause irreversible damage. Some studies have
advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al,
for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were
used. The purpose of this study is to evaluate the effect of using lower pressure
pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low
pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic
parameters including a reduction in the occurrence of post-operative ileus, reduced need for
narcotics post operatively, and a decrease in cardiopulmonary complications.
The study is a prospective randomized blinded cohort study. Patients who meet eligibility
criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 12mm Hg
or 8mm Hg. This will be done by computer generated randomization protocol. Surgeon and
patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over
the AirSeal™ system so that the surgeon(s) are not able to visualize the pneumoperitoneum
used during the procedure. The remainder of the procedure will be carried out based on
current standard of care.
All patients will be admitted post operatively and the same standardized order-set in EPIC
EHR will be used for all patients in order to control for other factors, such as opioid use,
to control for confounders.
specialties. However, the use of pneumoperitoneum comes with known risks given the change in
physiological parameters that accompany its utilization. The effects of increased
intra-abdominal pressure on cardiopulmonary function has been well documented. Increased
pressure on the large vessels may lead to decreased cardiac output and thereby decreased
blood flow to various organ systems and cause irreversible damage. Some studies have
advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al,
for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were
used. The purpose of this study is to evaluate the effect of using lower pressure
pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low
pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic
parameters including a reduction in the occurrence of post-operative ileus, reduced need for
narcotics post operatively, and a decrease in cardiopulmonary complications.
The study is a prospective randomized blinded cohort study. Patients who meet eligibility
criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 12mm Hg
or 8mm Hg. This will be done by computer generated randomization protocol. Surgeon and
patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over
the AirSeal™ system so that the surgeon(s) are not able to visualize the pneumoperitoneum
used during the procedure. The remainder of the procedure will be carried out based on
current standard of care.
All patients will be admitted post operatively and the same standardized order-set in EPIC
EHR will be used for all patients in order to control for other factors, such as opioid use,
to control for confounders.
Inclusion Criteria:
- Male 40 years of age or older
- Diagnosis of prostate cancer
- Have been evaluated to be fit for proposed surgery
- Patients able to consent
Exclusion Criteria:
- Patients unable to consent (cognitively impaired)
- Non-English speaking
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