Clinical trial NCT04394676: The Impact of Low Pressure Pneumo in RARP II
Official title: The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Radical Prostatectomy
Robotic Assisted Radical Prostatectomy
Lead sponsor: Metro Health, Michigan
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 600
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized Trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of Post-Operative Ileus
timeFrame: An average of 3 days
Secondary outcomes:
measure: Reduction in narcotic use
timeFrame: An average of 3 days
measure: Reduction in Estimated Blood Loss during RARP
timeFrame: An average of 1 hour
measure: Reduction in post operative complications as measured by Clavien-Dindo Complication Score
timeFrame: Up to 30 days after procedure
Other outcomes:
Locations:
city: Wyoming
country: United States
facility: Metro Health-University of Michigan Health
state: Michigan
Study officials:
affiliation: Michigan Urological Clinic
name: Thomas Maatman, DO
role: PRINCIPAL_INVESTIGATOR
References: