The Impact of Low Pressure Pneumo in RARP

• Sponsor: Metro Health, Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03370016
• Collaborator: (none)
• Enrollment: 222
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.4
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: Amount of Pneumoperitoneum Pressure applied during RARP	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 222 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Randomized TrialProspective, Randomized Trial
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Double Blinded
• Primary Purpose: Supportive Care
• Official Title: The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial
• Actual Study Start Date: Oct 17, 2017
• Actual Primary Completion Date: Mar 10, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reduction in pressure This group receives 8mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.	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)
Active Comparator: Stand Amount of Pressure This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures.	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)

Outcome Measures

Primary Outcome Measures

1. Reduction of Post-Operative Ileus [an average of 3 days]

   Reduction in the occurrence of Post-Operative Ileus after RARP

Secondary Outcome Measures

1. Reduction in narcotics [an average of 3 days]

   Reduction in the need for narcotics post operatively

2. Reduction in Estimated Blood Loss during RARP [an average of 1 hour]

   Reduced blood loss during robot assisted radical prostatectomy

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Metro Health	Wyoming	Michigan	United States	49519

Sponsors and Collaborators

• Metro Health, Michigan

Investigators

• Principal Investigator: Thomas Maatman, DO, Michigan Urological Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Metro Health, Michigan
• ClinicalTrials.gov Identifier: NCT03370016
• Other Study ID Numbers: RARP Pneumo Pressure Study
• First Posted: Dec 12, 2017
• Last Update Posted: Jan 7, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Metro Health, Michigan: Radical Prostatectomy; Robotic Assisted Radical Prostatectomy
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jan 7, 2021