The Impact of Low Pressure Pneumo in RARP II

Study Overview
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Brief Summary
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The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).

Detailed Description
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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.

Official Title
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The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial II

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Pressure applied during RARP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduction in Pressure<br>This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy. | Procedure: Pressure applied during RARP<br>* Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).<br>|
| Active Comparator: Standard Amount of Pressure<br>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. | Procedure: Pressure applied during RARP<br>* Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Post-Operative Ileus | Reduction in the occurrence of Post-Operative Ileus after RARP | An average of 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in narcotic use | Reduction in the need for narcotics post operatively | An average of 3 days | 
| Reduction in Estimated Blood Loss during RARP | Reduced blood loss during robot assisted radical prostatectomy | An average of 1 hour | 
| Reduction in post operative complications as measured by Clavien-Dindo Complication Score | Reduction in post operative complications as measured by Clavien-Dindo Complication Score | Up to 30 days after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical Prostatectomy, Robotic Assisted Radical Prostatectomy