Thrombembolism After Robot- Assisted Surgery in Urology

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04796740
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 18.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Cancer; Thrombosis; Embolism; Surgery--Complications

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 Design

• Study Type: Observational
• Anticipated Enrollment: 450 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Postoperative Arterial or Venous Thrombembolism After Robot- Assisted Surgery in Major Urological Procedures is in Some Cases a Severe Complication.
• Actual Study Start Date: Dec 17, 2019
• Anticipated Primary Completion Date: Aug 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. postoperative thrombembolism [through study completion, an average of 1 year]

   Arterial and venous thrombembolism after surgery

Secondary Outcome Measures

1. acute renal failure [through study completion, an average of 1 year]

   acute renal failure

2. pulmonary oedema [through study completion, an average of 1 year]

   pulmonary oedema

3. pneumonia [through study completion, an average of 1 year]

   pneumonia

4. wound infection [through study completion, an average of 1 year]

   wound infection

5. Major adverse cardiovascular events (MACE) [through study completion, an average of 1 year]

   nonfatal stroke, nonfatal myocardial infarction and cardiovascular death

6. ocular complications [through study completion, an average of 1 year]

   ocular complications

7. delirium [through study completion, an average of 1 year]

   delirium

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Schleswig-Holstein	Kiel	Schleswig-Holstein	Germany	24105

Sponsors and Collaborators

• University Hospital Schleswig-Holstein

Investigators

• Principal Investigator: Jochen Renner, Prof. Dr., University Hospital Schleswig-Holstein

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Dr. Jochen Renner, Clinical Professor, University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT04796740
• Other Study ID Numbers: IN-UDV_01
• First Posted: Mar 15, 2021
• Last Update Posted: Mar 15, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Jochen Renner, Clinical Professor, University Hospital Schleswig-Holstein: thrombembolism after robot-assisted surgery
• Additional relevant MeSH terms: Urologic Neoplasms; Thrombosis; Embolism

Study Results

No Results Posted as of Mar 15, 2021