Thrombembolism After Robot- Assisted Surgery in Urology

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04796740
• Other study ID #: IN-UDV_01
• Status: Recruiting
• Start date: December 17, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: University Hospital Schleswig-Holstein
• Contact: Jochen Renner, Prof. Dr.
• Phone: 004943150020801
• Email: jochen.renner[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Surgery--Complications
• Thrombosis
• Urologic Cancer
• Urologic Neoplasms

Locations

Country	Name	City	State
Germany	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Tyritzis SI, Wallerstedt A, Steineck G, Nyberg T, Hugosson J, Bjartell A, Wilderäng 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative thrombembolism	Arterial and venous thrombembolism after surgery	through study completion, an average of 1 year
Secondary	acute renal failure	acute renal failure	through study completion, an average of 1 year
Secondary	pulmonary oedema	pulmonary oedema	through study completion, an average of 1 year
Secondary	pneumonia	pneumonia	through study completion, an average of 1 year
Secondary	wound infection	wound infection	through study completion, an average of 1 year
Secondary	Major adverse cardiovascular events (MACE)	nonfatal stroke, nonfatal myocardial infarction and cardiovascular death	through study completion, an average of 1 year
Secondary	ocular complications	ocular complications	through study completion, an average of 1 year
Secondary	delirium	delirium	through study completion, an average of 1 year