Prostate Cancer
Conditions
Keywords
Radical Prostatectomy, Robotic Assisted Radical Prostatectomy
Brief summary
The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).
Detailed description
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.
Interventions
PROCEDUREAmount of Pneumoperitoneum Pressure applied during RARP
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 8 mmHg (experimental) or 12mm Hg (standard technique)
Sponsors
Metro Health, Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double Blinded
Intervention model description
Prospective, Randomized Trial
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Post-Operative Ileus | an average of 3 days | Reduction in the occurrence of Post-Operative Ileus after RARP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in narcotics | an average of 3 days | Reduction in the need for narcotics post operatively |
| Reduction in Estimated Blood Loss during RARP | an average of 1 hour | Reduced blood loss during robot assisted radical prostatectomy |
| Reduction in post operative complications as measured by Clavien-Dindo Complication Score | up to 30 days after procedure | Reduction in post operative complications as measured by Clavien-Dindo Complication Score |
Countries
United States
Outcome results
None listed