The Impact of Low Pressure Pneumo in RARP
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amount of Pneumoperitoneum Pressure applied during RARP
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Radical Prostatectomy, Robotic Assisted Radical Prostatectomy
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
Sites / Locations
- Metro Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reduction in pressure
Stand Amount of Pressure
Arm Description
This group receives 8mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.
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.
Outcomes
Primary Outcome Measures
Reduction of Post-Operative Ileus
Reduction in the occurrence of Post-Operative Ileus after RARP
Secondary Outcome Measures
Reduction in narcotics
Reduction in the need for narcotics post operatively
Reduction in Estimated Blood Loss during RARP
Reduced blood loss during robot assisted radical prostatectomy
Reduction in post operative complications as measured by Clavien-Dindo Complication Score
Reduction in post operative complications as measured by Clavien-Dindo Complication Score
Full Information
NCT ID
NCT03370016
First Posted
October 17, 2017
Last Updated
October 11, 2023
Sponsor
Metro Health, Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03370016
Brief Title
The Impact of Low Pressure Pneumo in RARP
Official Title
The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metro Health, Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Radical Prostatectomy, Robotic Assisted Radical Prostatectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized Trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double Blinded
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reduction in pressure
Arm Type
Experimental
Arm Description
This group receives 8mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.
Arm Title
Stand Amount of Pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Amount of Pneumoperitoneum Pressure applied during RARP
Intervention Description
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 8 mmHg (experimental) or 12mm Hg (standard technique)
Primary Outcome Measure Information:
Title
Reduction of Post-Operative Ileus
Description
Reduction in the occurrence of Post-Operative Ileus after RARP
Time Frame
an average of 3 days
Secondary Outcome Measure Information:
Title
Reduction in narcotics
Description
Reduction in the need for narcotics post operatively
Time Frame
an average of 3 days
Title
Reduction in Estimated Blood Loss during RARP
Description
Reduced blood loss during robot assisted radical prostatectomy
Time Frame
an average of 1 hour
Title
Reduction in post operative complications as measured by Clavien-Dindo Complication Score
Description
Reduction in post operative complications as measured by Clavien-Dindo Complication Score
Time Frame
up to 30 days after procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Maatman, DO
Organizational Affiliation
Michigan Urological Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Metro Health
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Impact of Low Pressure Pneumo in RARP
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