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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different pressure levels during robotically-assisted radical prostatectomy (RARP) might affect surgical outcomes. One group will undergo surgery with standard pressure, while another will experience slightly lower pressure (low pressure pneumoperitoneum). The researchers aim to determine if altering the pressure impacts patient recovery or postoperative well-being. Men aged 40 or older, diagnosed with prostate cancer, and fit for surgery may qualify for this trial. As an unphased trial, it provides a unique opportunity to contribute to innovative surgical research that could enhance recovery experiences for future patients.

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 prior data suggests that low pressure pneumoperitoneum is safe for prostate cancer surgery?

Research has shown that using lower pressure on the abdomen during robotic prostate surgery is generally safe. One study found that 12 mmHg of pressure, slightly less than the usual 15 mmHg, was well-tolerated by patients. This often led to fewer complications after surgery and a quicker recovery.

Another study found that lower pressure improved patient comfort after the procedure, resulting in less pain and a faster return to normal activities. Additionally, several studies confirm that this lower pressure does not increase surgical risks. Overall, both pressure levels used in these surgeries have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of using lower pressure during robotic-assisted radical prostatectomy (RARP) for prostate cancer. The standard practice involves using 15mm Hg of pressure, but this trial is testing whether reducing it to 12mm Hg can offer benefits. Lower pressure might reduce complications and improve recovery by minimizing pressure on the abdomen during surgery. This approach could lead to a gentler surgical experience and potentially better outcomes for patients, sparking interest in its potential advantages.

What evidence suggests that low pressure pneumoperitoneum is effective for prostate cancer surgery?

This trial will compare different pressures used during robotic-assisted prostate surgery. Research has shown that low pressure during such surgeries can improve patient recovery. Participants in the "Reduction in Pressure" arm will receive 12mm Hg of pneumoperitoneum pressure. Studies have found that this level helps patients feel better the day after surgery and reduces the risk of bowel problems. Another study found that lower pressure improves blood flow during the operation. Overall, using low pressure appears to make the surgery safer and speeds up recovery. Meanwhile, participants in the "Standard Amount of Pressure" arm will receive the standard 15mm Hg pressure. ^{4 6 7 8 9}

Who Is on the Research Team?

Thomas Maatman, DO

Principal Investigator

Michigan Urological Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12298137/

Versus Standard-Pressure Pneumoperitoneum on ... In conclusion, low-pressure PP (7 mmHg) during RARP significantly improves postoperative recovery in patients with obesity without compromising ...

2. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16099

Low‐ versus standard‐ pneumoperitoneum in patients ... Patients who underwent RARP at low Pnp pressure demonstrated better postoperative QoR on POD1 (mean difference = 10, 95% confidence interval [CI] ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678446/

The Impact of intra-abdominal Pressure on Perioperative ... These studies suggest that low IAP during RARP is associated with a significant reduction in the incidence of postoperative bowel obstruction ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767317301647

Low Pressure Robot-assisted Radical Prostatectomy With ... The purpose of the present study is to assess the effect on hemodynamics of a lower intra-abdominal CO2 pneumoperitoneum (8 mmHg), generated by insufflation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06784986

Impact of Using the Airseal System with Ultra-low ... The primary aim of this study is to compare the variance in intra-abdominal pressure (IAP) during robotic-assisted radical prostatectomy between patients using ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27059614/

Examining clinical outcomes utilizing low-pressure ... The objective of the study was to assess the safety and clinical outcomes of performing RARP utilizing LPP 12 mmHg with locally confined adenocarcinoma of the ...

7. mdpi.com mdpi.com/1648-9144/61/7/1253

A Retrospective Cohort Study Background and Objectives: Low-pressure pneumoperitoneum (PP) during robot-assisted radical prostatectomy (RARP) has been shown to improve postoperative ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8260086/

Is the use of ultra-low insufflation pressure safe and ... We performed a feasibility study of ultra-low–pressure robot-assisted laparoscopic radical prostatectomy (RARP). Material and methods. Prospective data related ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/09/NCT06915909/Prot_000.pdf

Robotic Prostatectomy Artificial Intelligence Low Pressure The benefits of laparoscopic surgery in terms of reduced complications, minimally invasiveness, patient comfort and reduced recovery time have ...