Robotic Surgical ProceduresNCT04235387
Haemodynamic Changes During Robotic Prostatectomy
An observational study of Robotic Surgical Procedures, run by Czech Technical University in Prague at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Robotic Surgical Procedures
- How many people
- 30 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Feb 2020to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020.
Who may be able to join
- patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020
Who cannot join
- body mass index over 35
- regular use of beta-blocking drugs
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Motol University Hospital
Prague, 15006
Tomas Vymazal, Ass.prof., +420224435400, tomas.vymazal@fnmotol.cz
Czech Technical University
Prague
About this study
Official title: 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.
Read the 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.
- Conditions
- Robotic Surgical Procedures
- Keywords
- robotic surgical procedures, laparoscopic surgical procedures, prostatectomy, haemodynamic changes, ventilatory changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic changes
Changes in mean arterial pressure.
Measured: Through study completion, an average of 1 year
Ventilatory changes
Changes in peak airway pressure and mean airway pressure.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Tomas Vymazal, Ass.prof., Study chair, University Hospital in Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235387
- Sponsor's protocol ID
- VentRes-2019-03-MR
- Status last verified
- Jan 2020
- First submitted
- 13 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Haemodynamic Parameters of Patients Undergoing Robotic Prostatectomy
- ClinicalTrials.gov ID
- NCT04235387
- Acronym / sponsor ID
- VentRes-2019-03-MR
- Conditions
- Robotic Surgical Procedures
- Keywords
- robotic surgical procedures, laparoscopic surgical procedures, prostatectomy, haemodynamic changes, ventilatory changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020.
Key inclusion criteria (1 listed)
- patients undergoing prostatectomy in University Hospital in Motol between 1st December 2019 and 30th April 2020
Key exclusion criteria (2 listed)
- body mass index over 35
- regular use of beta-blocking drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Haemodynamic changes
Time frame: Through study completion, an average of 1 year
Changes in mean arterial pressure.
Ventilatory changes
Time frame: Through study completion, an average of 1 year
Changes in peak airway pressure and mean airway pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Vymazal, Ass.prof. study chair
University Hospital in Motol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedures, run by Czech Technical University in Prague at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lenka Horakova, Dr. (+420607706498, horakle5@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic changes (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.