Prothrombotic Factors and Anaesthesia in Prostate Cancer

Surgery Clinical Trial

Official title:

Prothrombotic Factors , Angiogenic Growth Factor and Different Anaesthetic Techniques in Cancer Patients Undergoing Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998685
• Other study ID #: 550
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: November 5, 2014
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatic Cancer
• Prostatic Neoplasms
• Surgery

Intervention

Drug:
• Propofol

• remifentanyl

• Midazolam

• Fentanyl

• Sevoflurane

Locations

Country	Name	City	State
Italy	Department of Anaesthesiology, Regina Elena, National Cancer Institute	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of rate of prothrombotic markers and Vascular Endothelial Growth Factor (VEGF) variation		24 hours	Yes
Secondary	Free-desease survivall		2 years	Yes