Haemodynamic Changes During Robotic Prostatectomy

January 17, 2020 updated by: Czech Technical University in Prague

Analysis of Haemodynamic Parameters of Patients Undergoing Robotic Prostatectomy

The aim of the study is to analyse the haemodynamic and ventilatory changes in patients undergoing robotic prostatectomy, compared to standard laparoscopic prostatectomy.

Study Overview

Status

Unknown

Conditions

Detailed Description

Prostatectomy is a standard operation, increasingly performed using robotic assistance. During robotic assisted procedures, the intraabdominal pressures are usually higher than in standard laparoscopic operations which can pose a risk of cardiovascular and respiratory adverse effects. The aim of this study is to investigate the haemodynamic and ventilatory effects of robotic assisted prostatectomy, compared to standard laparoscopic prostatectomy.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha, Czechia
        • Czech Technical University
      • Praha, Czechia, 15006
        • Motol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020.

Description

Inclusion Criteria:

  • patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020

Exclusion Criteria:

  • body mass index over 35
  • regular use of beta-blocking drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Robotic prostatectomy
All patients undergoing robotic assisted prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring.
Laparoscopic prostatectomy
All patients undergoing standard laparoscopic prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemodynamic changes
Time Frame: Through study completion, an average of 1 year
Changes in mean arterial pressure.
Through study completion, an average of 1 year
Ventilatory changes
Time Frame: Through study completion, an average of 1 year
Changes in peak airway pressure and mean airway pressure.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Collaborators

University Hospital, Motol

Investigators

  • Study Chair: Tomas Vymazal, Ass.prof., University Hospital in Motol

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VentRes-2019-03-MR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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