Low Pressure Surgery for Prostate Cancer

Overseen By Kevin Keating, DO

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Metro Health, Michigan

Disqualifiers: Cognitively impaired, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Low Pressure Pneumoperitoneum in Low Pressure Surgery for Prostate Cancer?

Research shows that using lower pressure during robotic-assisted prostate surgery can reduce the length of hospital stay and the rate of post-operative ileus (a temporary lack of movement in the intestines), without increasing complications or affecting surgical outcomes. ^{1 2 3 4 5}

Is low pressure surgery for prostate cancer safe?

Research shows that using lower pressure during robotic-assisted prostate surgery is generally safe and may even reduce hospital stay and certain complications like post-operative ileus (temporary bowel blockage). Studies comparing different pressures found no significant increase in complications, making lower pressure a safe option. ^{1 2 3 4 6}

How does the low pressure treatment for prostate cancer differ from other treatments?

The low pressure treatment for prostate cancer involves using a reduced insufflation pressure during robotic-assisted surgery, which can lead to a shorter hospital stay and lower rates of post-operative ileus (a temporary lack of movement in the intestines) compared to standard pressure methods, without increasing complications. ^{1 2 3 4 7}

Research Team

Thomas Maatman, DO

Principal Investigator

Michigan Urological Clinic

Eligibility Criteria

This trial is for men aged 40 or older who have been diagnosed with prostate cancer and are fit to undergo robot-assisted surgery. Participants must be able to give consent, and those who cannot understand English or are cognitively impaired cannot join.

Inclusion Criteria

I have been deemed fit for surgery.

Patients able to consent

I am a man over 40 with prostate cancer.

Exclusion Criteria

Non-English speaking

I am unable to give consent due to cognitive impairment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic assisted radical prostatectomy (RARP) with either 15mm Hg or 12mm Hg pneumoperitoneum pressure

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative ileus, narcotic use, and blood loss

3 days

Follow-up

Participants are monitored for post-operative complications as measured by Clavien-Dindo Complication Score

30 days

Treatment Details

Interventions

• Pressure applied during RARP

Trial Overview The study is looking at the effects of using low pressure during a type of robotic surgery called RARP that's used to treat prostate cancer. It aims to see if lower pressure can improve outcomes or reduce complications.

Participant Groups

Group I: Reduction in Pressure Experimental Treatment 1 Intervention

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

Group II: Standard Amount of Pressure Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Metro Health, Michigan

Lead Sponsor

Trials

8

Recruited

3,600+

Findings from Research

In a study of 751 patients undergoing robot-assisted radical prostatectomy (RARP), using a pneumoperitoneum pressure of 20 mm Hg resulted in a significantly smaller decrease in hemoglobin levels compared to 15 mm Hg, indicating better blood stability during surgery.

The higher insufflation pressure of 20 mm Hg did not lead to increased complications or adverse effects on renal function, suggesting it is a safe option for improving surgical visibility without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Robot-Assisted Radical Prostatectomy with Pneumoperitoneum of 20 mm Hg: A Study of 751 Patients. Modi, PK., Kwon, YS., Patel, N., et al.[2018]

A meta-analysis of 4 studies involving 1319 patients found that using lower pressure pneumoperitoneum (≤12 mmHg) during robotic-assisted laparoscopic radical prostatectomy (RARP) significantly reduced the length of hospital stay by about 0.23 days and decreased the rate of post-operative ileus.

There were no significant differences in operation length, estimated blood loss, 30-day readmissions, or positive surgical margins when comparing lower pressure to standard pressure (>12 mmHg), suggesting that lower pressure is a safe alternative for RARP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower vs standard pressure pneumoperitoneum in robotic-assisted radical prostatectomy: a systematic review and meta-analysis. El-Taji, O., Howell-Etienne, J., Taktak, S., et al.[2023]

A feasibility study involving 112 patients showed that ultra-low-pressure robotic-assisted laparoscopic radical prostatectomy (RARP) at 6 mm Hg resulted in shorter console times (125 minutes) compared to standard pressure at 15 mm Hg (138 minutes), indicating improved efficiency.

The study found no significant differences in blood loss or complications between the two groups, suggesting that ultra-low-pressure RARP is a safe and effective option for patients, with potential for broader application in other robotic surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the use of ultra-low insufflation pressure safe and feasible in robot assisted radical prostatectomy. Johnstone, C., Hammond, J., Hanchanale, V.[2022]

In a study of 200 patients undergoing robotic-assisted radical prostatectomy (RARP), using a lower pressure pneumoperitoneum (12 mmHg) was found to be noninferior to the standard pressure (15 mmHg) in terms of safety and clinical outcomes.

The lower pressure did not significantly affect operative time, length of hospital stay, or rates of postoperative complications, suggesting that 12 mmHg can be a safe alternative during RARP for patients with locally confined prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining clinical outcomes utilizing low-pressure pneumoperitoneum during robotic-assisted radical prostatectomy. Christensen, CR., Maatman, TK., Maatman, TJ., et al.[2019]

In a study of 62 patients undergoing Robot-Assisted Radical Prostatectomy (RARP), the transperitoneal (TP) approach resulted in lower CO(2) reabsorption and a reduced risk of acidosis compared to the extra-peritoneal (EP) approach.

Both approaches showed similar postoperative complications, but the TP method is preferred from an anesthesiologic perspective due to better management of acid-base balance during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesiologic effects of transperitoneal versus extraperitoneal approach during robot-assisted radical prostatectomy: results of a prospective randomized study. Dal Moro, F., Crestani, A., Valotto, C., et al.[2022]

In a meta-analysis of six studies involving 2,271 patients, low intra-abdominal pressure (LIAP) during robotic-assisted radical prostatectomy (RARP) significantly reduced the incidence of postoperative ileus (POI) compared to high intra-abdominal pressure (HIAP), with a risk ratio of 0.42.

There were no significant differences in other perioperative outcomes such as hematoma, positive margin rate, urinary retention, operative time, or intraoperative blood loss between LIAP and HIAP groups, suggesting that LIAP is a safer option without compromising other surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of intra-abdominal Pressure on Perioperative Outcomes in Robotic-Assisted Radical Prostatectomy: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Yang, Y., Duan, Y., Wan, X., et al.[2022]

Using low-pressure pneumoperitoneum with anterior abdominal wall lifting during laparoscopic radical prostatectomy in elderly patients with localized prostate cancer leads to a satisfactory operating field and stable operational monitoring.

This technique not only reduces the duration of the surgery but also shortens hospitalization time and decreases the incidence of postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Low-pressure pneumoperitoneum with abdominal elevation in laparoscopic radical prosta-tectomy in elderly patients with a localized form of prostate cancer.] Komyakov, BK., Kolygina, EV., Nevirovich, ES., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety of Robot-Assisted Radical Prostatectomy with Pneumoperitoneum of 20 mm Hg: A Study of 751 Patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Lower vs standard pressure pneumoperitoneum in robotic-assisted radical prostatectomy: a systematic review and meta-analysis. [2023]

3. Turkey pubmed.ncbi.nlm.nih.gov

Is the use of ultra-low insufflation pressure safe and feasible in robot assisted radical prostatectomy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Examining clinical outcomes utilizing low-pressure pneumoperitoneum during robotic-assisted radical prostatectomy. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

Anesthesiologic effects of transperitoneal versus extraperitoneal approach during robot-assisted radical prostatectomy: results of a prospective randomized study. [2022]

6. Egypt pubmed.ncbi.nlm.nih.gov

The Impact of intra-abdominal Pressure on Perioperative Outcomes in Robotic-Assisted Radical Prostatectomy: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Low-pressure pneumoperitoneum with abdominal elevation in laparoscopic radical prosta-tectomy in elderly patients with a localized form of prostate cancer.] [2021]