Haemodynamic Changes During Robotic Prostatectomy

NCT ID: NCT04235387

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Robotic Surgical Procedures

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Robotic prostatectomy

All patients undergoing robotic assisted prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring.

No interventions assigned to this group

Laparoscopic prostatectomy

All patients undergoing standard laparoscopic prostatectomy in University Hospital in Motol during the project period. Monitored using standard non-invasive monitoring.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role collaborator

Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Vymazal, Ass.prof.

Role: STUDY_CHAIR

University Hospital in Motol

Locations

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Motol University Hospital

Prague, , Czechia

Site Status

Czech Technical University

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Lenka Horakova, Dr.

Role: CONTACT

+420607706498

Martin Rozanek, Ass.prof.

Role: CONTACT

+420224359960

Facility Contacts

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Tomas Vymazal, Ass.prof.

Role: primary

+420224435400

Other Identifiers

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VentRes-2019-03-MR

Identifier Type: -

Identifier Source: org_study_id

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