Clinical trial NCT01998685: Prothrombotic Factors and Anaesthesia in Prostate Cancer
Official title: Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Cancer
Surgery
Keywords: Prostatectomy
Coagulation Factor
Balanced Anesthesia
Intravenous Anesthesia,
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2013-12-02
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).

Detailed description: The utility of anti-thrombotic prophylaxis in cancer patients undergoing laparoscopic radical prostatectomy (LRP) is still controversial. Moreover, different anaesthetic techniques could modify coagulant factors. Thus, in this study we will be to investigate the variations of pro- and anti-coagulant and fibrinolytic factors in two established types of anaesthesia in patients with prostate cancer undergoing elective LRP.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed cancer of the prostate
* histological Gleason score evaluation.

Exclusion Criteria:

* ASA \>2
* metabolic equivalent task \< 4
* BMI\>30
* no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy
* history of abnormal bleeding, or abnormal coagulant factors
* sepsis within the last 2 weeks
* previous new adjuvant treatments (chemo, hormone, and radiotherapy)
* non-steroid , anti-inflammatory and statins drugs for at least 2 wks before surgery
* venous or arterial thromboembolism within the last 3 months, peripheral venous disease
* neurological disease with extremity paresis
* chronic liver disease
* pre-operative haemoglobin concentration \< 9 mg dl-1
* prolonged duration of surgery (\>3 hrs)
* peri-operative blood transfusion
* not adequate material for laboratory testing

Primary outcomes:
measure: Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation
timeFrame: 24 hours
Secondary outcomes:
measure: Free-desease survivall
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Anaesthesiology, Regina Elena, National Cancer Institute
Study officials:
affiliation: Department of Anaesthesiology, Regina Elena, National Cancer Institute, Via Elio Chianesi 53, 00144 Roma (Italy); Tel. +39 0652662942, FAX: +39 0652662993; e-mail: forastiere@ifo.it
name: Ester Forastiere, MD
role: STUDY_DIRECTOR
References:
citation: Sofra M, Antenucci A, Gallucci M, Mandoj C, Papalia R, Claroni C, Monteferrante I, Torregiani G, Gianaroli V, Sperduti I, Tomao L, Forastiere E. Perioperative changes in pro and anticoagulant factors in prostate cancer patients undergoing laparoscopic and robotic radical prostatectomy with different anaesthetic techniques. J Exp Clin Cancer Res. 2014 Aug 17;33(1):63. doi: 10.1186/s13046-014-0063-z.