The Impact of Low Pressure Pneumo in RARP II
1 other identifier
interventional
600
1 country
1
Brief Summary
The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Aug 2020
Typical duration for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedOctober 12, 2023
March 1, 2023
3.9 years
May 14, 2020
October 11, 2023
Conditions
Keywords
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 narcotic use
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
EXPERIMENTALThis group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.
Standard Amount of Pressure
ACTIVE COMPARATORThis group receives 15mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures.
Interventions
Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metro Health-University of Michigan Health
Wyoming, Michigan, 49519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Maatman, DO
Michigan Urological Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2020
First Posted
May 19, 2020
Study Start
August 4, 2020
Primary Completion
June 30, 2024
Study Completion
June 30, 2025
Last Updated
October 12, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share