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Trial record 75 of 151 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

The Impact of Low Pressure Pneumo in RARP

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ClinicalTrials.gov Identifier: NCT03370016
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Metro Health, Michigan

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, 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 : October 17, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Reduction of Post-Operative Ileus [ Time Frame: an average of 3 days ]
    Reduction in the occurrence of Post-Operative Ileus after RARP


Secondary Outcome Measures :
  1. Reduction in narcotics [ Time Frame: an average of 3 days ]
    Reduction in the need for narcotics post operatively

  2. Reduction in Estimated Blood Loss during RARP [ Time Frame: 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 [ Time Frame: up to 30 days after procedure ]
    Reduction in post operative complications as measured by Clavien-Dindo Complication Score



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370016


Contacts
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Contact: Jaschar Shakuri-Rad, DO 616-252-5026 jaschar.shakuri-rad@metrogr.org
Contact: Thomas Maatman, DO 616-252-5026 maatmant@aol.com

Locations
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United States, Michigan
Metro Health Recruiting
Wyoming, Michigan, United States, 49519
Contact: Maureen Oostendorp, MM    616-252-5026    maureen.oostendorp@metrogr.org   
Contact: Carmen Heaney, BSN, RN    616-252-5020    carmen.heaney@metrogr.org   
Sub-Investigator: Jaschar Shakuri-Rad, DO         
Sponsors and Collaborators
Metro Health, Michigan
Investigators
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Principal Investigator: Thomas Maatman, DO Michigan Urological Clinic

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Responsible Party: Metro Health, Michigan
ClinicalTrials.gov Identifier: NCT03370016     History of Changes
Other Study ID Numbers: RARP Pneumo Pressure Study
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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