Sentinel Lymph Node Detection in Prostate Surgery by Laparoscopy

Not Applicable

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Procedure: lymph nod detection

• Registration Number: NCT01296217
• Lead Sponsor: Centre René Gauducheau

Brief Summary

In this study the investigators want to determine if the detection of lymph node is applicable in prostatectomy by laparoscopy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Age> 18 years
• Diagnosis of invasive cancer of the prostate (T1 or T2 or T3)
• PSA ≥ 4,
• Gleason ≥ 6
• No treatment prior to surgery
• Indication of lymphadenectomy by coeliscopique
• ECOG or Karnofsky index 2
• Patient information and signed informed consent

Exclusion Criteria

• neoadjuvant hormone therapy
• Interventions prior pelvic
• Patients who received anterior resection of part of prostate
• Patient or denied having an altered mental status
• Any contre indication to laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lymph nod detection	lymph nod detection	-

Primary Outcome Measures

Name	Time	Method
detection rate and false-negative rate for the sentinel lymph node detection	The day of at laparoscopy (Day 1)

Trial Locations

Locations (1)

Centre René Gauducheau; 🇫🇷 Nantes, France