NCT04796740

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

December 17, 2020

Last Update Submit

March 10, 2021

Conditions

Urologic CancerThrombosisEmbolismSurgery--Complications

Keywords

thrombembolism after robot-assisted surgery

Outcome Measures

Primary Outcomes (1)

  • postoperative thrombembolism

    Arterial and venous thrombembolism after surgery

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • acute renal failure

    through study completion, an average of 1 year

  • pulmonary oedema

    through study completion, an average of 1 year

  • pneumonia

    through study completion, an average of 1 year

  • wound infection

    through study completion, an average of 1 year

  • Major adverse cardiovascular events (MACE)

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collective of patients with bladder- and/or prostate cancer scheduled for laporoscopic robot-assited radical cystectomy and/or prostatectomy

You may qualify if:

  • over 18 years of age
  • scheduled for urological surgery (cystectomy and/or prostatectomy)
  • signed basical declaration of consent

You may not qualify if:

  • absent or unsigned basical declaration of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Related 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.

    PMID: 24960494BACKGROUND

  • 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.

    PMID: 25443917BACKGROUND

  • 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.

    PMID: 25158271BACKGROUND

  • 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.

    PMID: 18005777BACKGROUND

MeSH Terms

Conditions

Urologic NeoplasmsThrombosisEmbolism

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Jochen Renner, Prof. Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen Renner, Prof. Dr.

CONTACT

004943150020801jochen.renner@uksh.de

Ulf Lorenzen, Dr.

CONTACT

004943150020801ulf.lorenzen@uksh.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 17, 2020

First Posted

March 15, 2021

Study Start

December 17, 2019

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)