Clinical trial NCT04796740: Thrombembolism After Robot- Assisted Surgery in Urology
Official title: Postoperative Arterial or Venous Thrombembolism After Robot- Assisted Surgery in Major Urological Procedures is in Some Cases a Severe Complication.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urologic Cancer
Thrombosis
Embolism
Surgery--Complications
Keywords: thrombembolism after robot-assisted surgery
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: postoperative thrombembolism
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: acute renal failure
timeFrame: through study completion, an average of 1 year
measure: pulmonary oedema
timeFrame: through study completion, an average of 1 year
measure: pneumonia
timeFrame: through study completion, an average of 1 year
measure: wound infection
timeFrame: through study completion, an average of 1 year
measure: Major adverse cardiovascular events (MACE)
timeFrame: through study completion, an average of 1 year
measure: ocular complications
timeFrame: through study completion, an average of 1 year
measure: delirium
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Jochen Renner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abel EJ, Wong K, Sado M, Leverson GE, Patel SR, Downs TM, Jarrard DF. Surgical operative time increases the risk of deep venous thrombosis and pulmonary embolism in robotic prostatectomy. JSLS. 2014 Apr-Jun;18(2):282-7. doi: 10.4293/108680813X13693422518551.
citation: Mehrazin R, Piotrowski Z, Egleston B, Parker D, Tomaszweski JJ, Smaldone MC, Abbosh PH, Ito T, Bloch P, Iffrig K, Bilusic M, Chen DY, Viterbo R, Greenberg RE, Uzzo RG, Kutikov A. Is extended pharmacologic venous thromboembolism prophylaxis uniformly safe after radical cystectomy? Urology. 2014 Nov;84(5):1152-6. doi: 10.1016/j.urology.2014.06.058. Epub 2014 Oct 24.
citation: Tyritzis SI, Wallerstedt A, Steineck G, Nyberg T, Hugosson J, Bjartell A, Wilderang U, Thorsteinsdottir T, Carlsson S, Stranne J, Haglind E, Wiklund NP; LAPPRO Steering Committee. Thromboembolic complications in 3,544 patients undergoing radical prostatectomy with or without lymph node dissection. J Urol. 2015 Jan;193(1):117-25. doi: 10.1016/j.juro.2014.08.091. Epub 2014 Aug 23.
citation: Hope WW, Demeter BL, Newcomb WL, Schmelzer TM, Schiffern LM, Heniford BT, Sing RF. Postoperative pulmonary embolism: timing, diagnosis, treatment, and outcomes. Am J Surg. 2007 Dec;194(6):814-8; discussion 818-9. doi: 10.1016/j.amjsurg.2007.08.014.