Thrombembolism After Robot- Assisted Surgery in Urology

NCT ID: NCT04796740

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-17

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Urologic Cancer Thrombosis Embolism Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Dr. Jochen Renner

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Renner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jochen Renner, Prof. Dr.

Role: CONTACT

004943150020801

Ulf Lorenzen, Dr.

Role: CONTACT

004943150020801

Facility Contacts

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Jochen Renner, Prof. Dr.

Role: primary

004943150020801

Ulf Lorenzen, Dr.

Role: backup

004943150020801

References

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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.

Reference Type BACKGROUND
PMID: 24960494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25443917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25158271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18005777 (View on PubMed)

Other Identifiers

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IN-UDV_01

Identifier Type: -

Identifier Source: org_study_id

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