Thrombembolism After Robot- Assisted Surgery in Urology

March 10, 2021 updated by: Dr. Jochen Renner, University Hospital Schleswig-Holstein

Postoperative Arterial or Venous Thrombembolism After Robot- Assisted Surgery in Major Urological Procedures is in Some Cases a Severe Complication.

Cancer patients have an increased risk of perioperative complications undergoing surgery procedures. Postoperative complications caused by thrombembolic events after robot- assisted surgery in major urological procedures have been reported and associated with an increased lenght of stay in the hospital. We therefore aimed to investigate in a retrospective analysis 250 patients undergoing robotic-assisted radical cystectomy and prostatectomy procedures for risk factors for thrombembolic events in this specific patient population.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Postoperative arterial or venous thrombembolism after robotic- assisted surgery in major urological procedures are reported severe complications in this patient population.

After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of approximately 250 robot- assisted radical cystectomy and radical prostatectomy surgical procedures. In due consideration of perioperative prophylaxis of thrombembolic Events we determine the clinical and radiological signs of venous or arterial thrombembolism postoperatively with a particular focus on early postoperative pulmonary embolism events.

This is a retrospective analysis of 250 robotic-assisted radical cystectomy and radical prostatectomy surgical procedures.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein
        • Contact:
        • Contact:

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Collective of patients with bladder- and/or prostate cancer scheduled for laporoscopic robot-assited radical cystectomy and/or prostatectomy

Description

Inclusion Criteria:

  • over 18 years of age
  • scheduled for urological surgery (cystectomy and/or prostatectomy)
  • signed basical declaration of consent

Exclusion Criteria:

  • absent or unsigned basical declaration of consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative thrombembolism
Time Frame: through study completion, an average of 1 year
Arterial and venous thrombembolism after surgery
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute renal failure
Time Frame: through study completion, an average of 1 year
acute renal failure
through study completion, an average of 1 year
pulmonary oedema
Time Frame: through study completion, an average of 1 year
pulmonary oedema
through study completion, an average of 1 year
pneumonia
Time Frame: through study completion, an average of 1 year
pneumonia
through study completion, an average of 1 year
wound infection
Time Frame: through study completion, an average of 1 year
wound infection
through study completion, an average of 1 year
Major adverse cardiovascular events (MACE)
Time Frame: through study completion, an average of 1 year
nonfatal stroke, nonfatal myocardial infarction and cardiovascular death
through study completion, an average of 1 year
ocular complications
Time Frame: through study completion, an average of 1 year
ocular complications
through study completion, an average of 1 year
delirium
Time Frame: through study completion, an average of 1 year
delirium
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

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Jochen Renner, Prof. Dr., University Hospital Schleswig-Holstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

December 17, 2019

Primary Completion (ANTICIPATED)

August 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

March 10, 2021

First Posted (ACTUAL)

March 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN-UDV_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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