Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2020-08-04
2025-06-30
Brief Summary
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Detailed Description
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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 15mm Hg or 12mm 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 insufflation 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 orderset in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Reduction in Pressure
This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.
Pressure applied during RARP
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).
Standard Amount of Pressure
This group receives 15mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures.
Pressure applied during RARP
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).
Interventions
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Pressure applied during RARP
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prostate cancer
* Have been evaluated to be fit for proposed surgery
* Patients able to consent
Exclusion Criteria
• Non-English speaking
40 Years
MALE
No
Sponsors
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Metro Health, Michigan
OTHER
Responsible Party
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Principal Investigators
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Thomas Maatman, DO
Role: PRINCIPAL_INVESTIGATOR
Michigan Urological Clinic
Locations
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Metro Health-University of Michigan Health
Wyoming, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB2020-007
Identifier Type: -
Identifier Source: org_study_id
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