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NCT04235387 Clinical Trial

Haemodynamic Changes During Robotic Prostatectomy

Robotic Surgical Procedures Clinical Trial

Official title:
Analysis of Haemodynamic Parameters of Patients Undergoing Robotic Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04235387
Other study ID # VentRes-2019-03-MR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date May 31, 2021

Study information
Verified date January 2020
Source Czech Technical University in Prague
Contact Lenka Horakova, Dr.
Phone +420607706498
Email horakle5@fbmi.cvut.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date May 31, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia Czech Technical University Praha
Czechia Motol University Hospital Praha

Sponsors (2)
Lead Sponsor Collaborator
Czech Technical University in Prague University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Haemodynamic changes Changes in mean arterial pressure. Through study completion, an average of 1 year
Primary Ventilatory changes Changes in peak airway pressure and mean airway pressure. Through study completion, an average of 1 year
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