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Procedure

Low Pressure Surgery for Prostate Cancer

N/A

Recruiting

Led By Thomas Maatman, DO

Research Sponsored by Metro Health, Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have been evaluated to be fit for proposed surgery

Male 40 years of age or older with a diagnosis of prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after procedure

Awards & highlights

Study Summary

This trial is testing if low pressure during surgery helps with prostatectomy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include typical surgical complications such as infection, bleeding, pain at the site of surgery, and issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been deemed fit for surgery.

Select...

I am a man over 40 with prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction of Post-Operative Ileus

Secondary outcome measures

Reduction in Estimated Blood Loss during RARP

Reduction in narcotic use

Reduction in post operative complications as measured by Clavien-Dindo Complication Score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reduction in PressureExperimental Treatment1 Intervention

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

Group II: Standard Amount of PressureActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Metro Health, MichiganLead Sponsor

6 Previous Clinical Trials

2,996 Total Patients Enrolled

1 Trials studying Prostate Cancer

222 Patients Enrolled for Prostate Cancer

Thomas Maatman, DOPrincipal InvestigatorMichigan Urological Clinic

1 Previous Clinical Trials

222 Total Patients Enrolled

1 Trials studying Prostate Cancer

222 Patients Enrolled for Prostate Cancer

Media Library

Pressure applied during RARP (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04394676 — N/A

Prostate Cancer Research Study Groups: Standard Amount of Pressure, Reduction in Pressure

Prostate Cancer Clinical Trial 2023: Pressure applied during RARP Highlights & Side Effects. Trial Name: NCT04394676 — N/A

Pressure applied during RARP (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394676 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for the clinical trial?

"Per the information available on clinicaltrials.gov, this research is actively recruiting volunteers. The study was first made public in August 2020 and has been revised as recently as January 2021."

Answered by AI

How numerous are the participants of this trial?

"Affirmative, the clinicaltrials.gov database confirms that this experiment is actively searching for participants. It was initially announced on August 4th 2020 and its most recent amendment occurred on January 6th 2021, with 600 individuals requested from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Low Pressure Pneumo in RARP II

2020. "The Impact of Low Pressure Pneumo in RARP II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04394676.