The Impact of Low Pressure Pneumo in RARP II
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Pressure applied during RARP
- Registration Number
- NCT04394676
- Lead Sponsor
- Metro Health, Michigan
- 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. A previously completed study concluded a reduction in post-operative ileus at a pneumoperitoneum pressure of 8 mm Hg vs 12 mm Hg. This new study will evaluate the standard pneumoperitoneum pressure of 15 mm Hg vs 12 mm Hg in order to validate the previous study vs the standard pneumoperitoneum pressure.
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 15mm Hg or 12mm 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 insufflation 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 orderset in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 600
- Male 40 years of age or older
- Diagnosis of prostate cancer
- Have been evaluated to be fit for proposed surgery
- Patients able to consent
- Patients unable to consent (cognitively impaired)
• Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Amount of Pressure Pressure applied during RARP This group receives 15mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures. Reduction in Pressure Pressure applied during RARP This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.
- Primary Outcome Measures
Name Time Method Reduction of Post-Operative Ileus An average of 3 days Reduction in the occurrence of Post-Operative Ileus after RARP
- Secondary Outcome Measures
Name Time Method Reduction in narcotic use 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
Trial Locations
- Locations (1)
Metro Health-University of Michigan Health
🇺🇸Wyoming, Michigan, United States