Evaluating low pressure during robotic prostate surgery
The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial II
This study is testing if using lower pressure during robotic prostate surgery can help men with prostate cancer recover better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Metro Health, Michigan Academic / other |
| Locations | 1 site (Wyoming, Michigan) |
| Trial ID | NCT04394676 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical significance of using low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP) for prostate cancer. The researchers will compare the standard pneumoperitoneum pressure of 15 mm Hg with a lower pressure of 12 mm Hg to determine its effects on post-operative outcomes. The hypothesis is that lower pressure may lead to improved physiological parameters, reducing complications such as post-operative ileus and the need for narcotics. The study will be conducted as a prospective randomized trial to validate previous findings regarding lower pressures.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 40 years or older diagnosed with prostate cancer who are fit for surgery and able to provide consent.
Not a fit: Patients who are cognitively impaired or non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and fewer complications for patients undergoing robotic prostate surgery.
How similar studies have performed: Previous studies have shown success with lower pressure pneumoperitoneum, indicating potential for this approach to be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wyoming, Michigan
- Metro Health-University of Michigan Health — Wyoming, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Maatman, DO — Michigan Urological Clinic
- Study coordinator: Kevin Keating, DO
- Email: kevin.keating@umhwest.org
- Phone: 616-252-5026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.