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Clinical Trials/NCT03370016
NCT03370016
Completed
Not Applicable

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

Metro Health, Michigan1 site in 1 country222 target enrollmentOctober 17, 2017
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Metro Health, Michigan
Enrollment
222
Locations
1
Primary Endpoint
Reduction of Post-Operative Ileus
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 17, 2017
End Date
June 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Metro Health, Michigan
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Reduction of Post-Operative Ileus

Time Frame: an average of 3 days

Reduction in the occurrence of Post-Operative Ileus after RARP

Secondary Outcomes

  • Reduction in narcotics(an average of 3 days)
  • Reduction in post operative complications as measured by Clavien-Dindo Complication Score(up to 30 days after procedure)
  • Reduction in Estimated Blood Loss during RARP(an average of 1 hour)

Study Sites (1)

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