The Impact of Low Pressure Pneumo in RARP

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370016
• Other study ID #: RARP Pneumo Pressure Study
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2023
• Source: Metro Health, Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 30, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Amount 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)

Locations

Country	Name	City	State
United States	Metro Health	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Metro Health, Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Post-Operative Ileus	Reduction in the occurrence of Post-Operative Ileus after RARP	an average of 3 days
Secondary	Reduction in narcotics	Reduction in the need for narcotics post operatively	an average of 3 days
Secondary	Reduction in Estimated Blood Loss during RARP	Reduced blood loss during robot assisted radical prostatectomy	an average of 1 hour
Secondary	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