Impact de la technique anesthésique et analgésique sur le risque de récidive biologique de cancer de la prostate - Péri-Prostate

• Conditions: prostate cancer; MedDRA version: 9.1Level: LLTClassification code 10060862Term: Prostate cancer

• Registration Number: EUCTR2009-009114-40-FR
• Lead Sponsor: Hopital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Age > 75 years
- Radical prostatectomy
- Gleason score <9
- PSA < 20 ng/ml
- Cancer Stage < T3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age lower than 18 years,
- Allergy to propofol, peanut or soya, remifentanil, morphine, muscle relaxant, or to a component,
- History of hypersensibility to remifentanil or to a derivate of fentanyl,
- Patients receiving a psychotropic treatment, and patients taking agonist-antagonist opiates,
- Presence of a central neurological disorder or a lesion cerebral,
- Contra-indication to an epidural anesthesia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to analyze the influence epidural anesthesia and analgesia on the risk of biological recurrence of cancer prostate;Secondary Objective: The main secondary objectives are :<br>- intraoperative blood requirements<br>- post-operative rehabilitation (especially pain control, mobilization, oral feeding, postoperative ileus).;Primary end point(s): The primary endpoint is the biological recurrence (PSA) of prostate cancer.