The Impact of Low Pressure Pneumo in RARP

NCT03370016 | Completed DMC

• 1 other identifier: RARP Pneumo Pressure Study
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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

Keywords

Radical Prostatectomy; Robotic Assisted Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Reduction of Post-Operative Ileus

  Reduction in the occurrence of Post-Operative Ileus after RARP

  an average of 3 days

Secondary Outcomes (3)

• Reduction in narcotics

  an average of 3 days

• Reduction in Estimated Blood Loss during RARP

  an average of 1 hour

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

  up to 30 days after procedure

Study Arms (2)

Reduction in pressure

EXPERIMENTAL

This group receives 8mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.

Procedure: Amount of Pneumoperitoneum Pressure applied during RARP

Stand Amount of Pressure

ACTIVE COMPARATOR

This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures.

Procedure: Amount of Pneumoperitoneum Pressure applied during RARP

Interventions

Amount of Pneumoperitoneum Pressure applied during RARP PROCEDURE

Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 8 mmHg (experimental) or 12mm Hg (standard technique)

Reduction in pressure; Stand Amount of Pressure

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 40 years of age or older
• Diagnosis of prostate cancer
• Have been evaluated to be fit for proposed surgery
• Patients able to consent

You may not qualify if:

• Patients unable to consent (cognitively impaired)
• Non-English speaking

Sponsors & Collaborators

• Metro Health, Michigan: lead

Study Sites (1)

Metro Health

Wyoming, Michigan, 49519, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Maatman, DO

  Michigan Urological Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized Trial

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: December 12, 2017
• Study Start: October 17, 2017
• Primary Completion: March 10, 2020
• Study Completion: June 30, 2020
• Last Updated: October 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)