NCT04235387

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 13, 2020

Last Update Submit

January 17, 2020

Conditions

Robotic Surgical Procedures

Keywords

robotic surgical procedureslaparoscopic surgical proceduresprostatectomyhaemodynamic changesventilatory changes

Outcome Measures

Primary Outcomes (2)

  • Haemodynamic changes

    Changes in mean arterial pressure.

    Through study completion, an average of 1 year

  • Ventilatory changes

    Changes in peak airway pressure and mean airway pressure.

    Through study completion, an average of 1 year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstatectomy performed only in male patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Motol University Hospital

Prague, 15006, Czechia

Location

Czech Technical University

Prague, Czechia

Location

Study Officials

  • Tomas Vymazal, Ass.prof.

    University Hospital in Motol

    STUDY CHAIR

Central Study Contacts

Lenka Horakova, Dr.

CONTACT

+420607706498horakle5@fbmi.cvut.cz

Martin Rozanek, Ass.prof.

CONTACT

+420224359960rozanek@fbmi.cvut.cz

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 21, 2020

Study Start

February 1, 2020

Primary Completion

December 30, 2020

Study Completion

May 31, 2021

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

CZ(2)