Recruiting

Low Pressure Pneumo

Sponsor:

Metro Health, Michigan

Code:

NCT04394676

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Pressure applied during RARP

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Study ID

NCT04394676

Start date

Aug 4, 2020

Status verified date

Mar, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Reduction in Pressure

This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.

active comparator: 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.

Interventions

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).

Primary outcome measure

  • Reduction of Post-Operative Ileus [ Time Frame: An average of 3 days ]

Central Contacts and Locations

Central contacts

Kevin Keating, DO

616-252-5026kevin.keating@umhwest.org

Thomas Maatman, DO

616-252-5026maatmant@aol.com

Locations

Metro Health-University of Michigan Health

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Cindy Karl, BSN

616-252-4971cindy.karl@metrogr.org

Joan Westendorp, BSN

616-252-4973joan.westendorp@umhwest.org

More Information

Sponsor

Metro Health, Michigan

Last update posted

Oct 12, 2023

Last verified

Mar, 2023

Keywords

  • Radical Prostatectomy
  • Robotic Assisted Radical Prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Metro Health, Michigan on 2023-10-12.