Thrombembolism After Robot- Assisted Surgery in Urology

• Conditions: Embolism; Surgery--Complications; Thrombosis; Urologic Cancer

• Registration Number: NCT04796740
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2020-12-17
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative thrombembolism	through study completion, an average of 1 year	Arterial and venous thrombembolism after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Schleswig-Holstein, Germany