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Completed

NCT Number: NCT03370016

The Impact of Low Pressure Pneumo in RARP

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

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Metro Health

Wyoming, Michigan, 49519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amount of Pneumoperitoneum Pressure applied during RARP

Procedure

Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 8 mmHg (experimental) or 12mm Hg (standard technique)

Primary outcomes

  1. Reduction of Post-Operative Ileus

    Time frame: an average of 3 days

    Reduction in the occurrence of Post-Operative Ileus after RARP

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Metro Health, Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2017
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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