Thrombembolism After Robot- Assisted Surgery in Urology

Rekrutierend

NCT-Nummer:
NCT04796740

Studienbeginn:
Dezember 2019

Letztes Update:
15.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Urologic Neoplasms, Thrombosis, Embolism

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Schleswig-Holstein

Collaborator:
-

Studienleiter

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

Kontakt

Jochen Renner, Prof. Dr.
Kontakt:
Phone: 004943150020801
E-Mail: jochen.renner@uksh.de» Kontaktdaten anzeigen

Ulf Lorenzen, Dr.
Kontakt:
Phone: 004943150020801
E-Mail: ulf.lorenzen@uksh.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Jochen Renner, Prof. Dr.
Phone: 004943150020801
E-Mail: jochen.renner@uksh.de

Ulf Lorenzen, Dr.
Phone: 004943150020801
E-Mail: ulf.lorenzen@uksh.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. postoperative thrombembolism (Time Frame - through study completion, an average of 1 year):
Arterial and venous thrombembolism after surgery

Secondary outcome:

1. acute renal failure (Time Frame - through study completion, an average of 1 year):
acute renal failure

2. pulmonary oedema (Time Frame - through study completion, an average of 1 year):
pulmonary oedema

3. pneumonia (Time Frame - through study completion, an average of 1 year):
pneumonia

4. wound infection (Time Frame - through study completion, an average of 1 year):
wound infection

5. Major adverse cardiovascular events (MACE) (Time Frame - through study completion, an average of 1 year):
nonfatal stroke, nonfatal myocardial infarction and cardiovascular death

6. ocular complications (Time Frame - through study completion, an average of 1 year):
ocular complications

7. delirium (Time Frame - through study completion, an average of 1 year):
delirium

Quelle: ClinicalTrials.gov