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Clinical Trials/NCT04796740
NCT04796740
Unknown
Not Applicable

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

University Hospital Schleswig-Holstein1 site in 1 country450 target enrollmentDecember 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urologic Cancer
Sponsor
University Hospital Schleswig-Holstein
Enrollment
450
Locations
1
Primary Endpoint
postoperative thrombembolism
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2019
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Dr. Jochen Renner

Clinical Professor

University Hospital Schleswig-Holstein

Eligibility Criteria

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

Outcomes

Primary Outcomes

postoperative thrombembolism

Time Frame: through study completion, an average of 1 year

Arterial and venous thrombembolism after surgery

Secondary Outcomes

  • wound infection(through study completion, an average of 1 year)
  • pulmonary oedema(through study completion, an average of 1 year)
  • Major adverse cardiovascular events (MACE)(through study completion, an average of 1 year)
  • ocular complications(through study completion, an average of 1 year)
  • delirium(through study completion, an average of 1 year)
  • acute renal failure(through study completion, an average of 1 year)
  • pneumonia(through study completion, an average of 1 year)

Study Sites (1)

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