The Impact of Low Pressure Pneumo in RARP

October 11, 2023 updated by: Metro Health, Michigan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Metro Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Post-Operative Ileus
Time Frame: an average of 3 days
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 narcotics
Time Frame: an average of 3 days
Reduction in the need for narcotics post operatively
an average of 3 days
Reduction in Estimated Blood Loss during RARP
Time Frame: an average of 1 hour
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
Time Frame: up to 30 days after procedure
Reduction in post operative complications as measured by Clavien-Dindo Complication Score
up to 30 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metro Health, Michigan

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2017

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RARP Pneumo Pressure Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Amount of Pneumoperitoneum Pressure applied during RARP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe