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Robotic Laparoscopic Radical Prostatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292019
First Posted: February 15, 2006
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
February 14, 2006
February 15, 2006
August 28, 2017
March 4, 2004
June 30, 2016   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00292019 on ClinicalTrials.gov Archive Site
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Robotic Laparoscopic Radical Prostatectomy
Robotic Laparoscopic Radical Prostatectomy
This is a pilot study to evaluate the role of RALRP in the management of localized prostate cancer.
To establish a robotic-assisted laparoscopic radical prostatectomy programme at the University of Western Ontario/London Health Sciences Centre and to critically evaluate the role of this programme in the management of localized prostate cancer in surgical candidates Details of surgical procedure, operative outcome, patient outcome including quality of life will be collected.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Prostate cancer patients eligible for a radical prostatectomy
Prostate Cancer
Procedure: Laparoscopic
Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
Robotic prostatectomy
Patients who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robotics.
Intervention: Procedure: Laparoscopic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 30, 2016
June 30, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Informed Consent
  2. Locally confined, stage T1a, T2a or T2b prostate cancer
  3. Aged 40-65 and judged by the study doctor to be a suitable candidate for a radical prostatectomy.
  4. Serum prostate specific antigen equal to or less than 10mg/ml
  5. Histologically confirmed adenocarcinoma of the prostate
  6. Gleason score equal to or less than 7
  7. Life expectancy of greater than 10 years.
  8. Prostate size on TRUS measurement less than 40 grams

Exclusion Criteria:

  1. Patients who have undergone prior hormone therapy.
  2. Patients with a previous transurethral resectioning of the prostate (TURP)
  3. History of other cancers other than basal cell carcinoma.
  4. Patients with any prior abdominal surgery.
  5. Any condition, or history of illness or surgery than, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (eg significant cardiovascular conditions)
  6. Patients with a large median lobe of the prostate. -

Exclusion Criteria:

Sexes Eligible for Study: Male
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00292019
R-04-030
10280
No
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Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Joseph Chin, MD< FRCSC London Health Sciences Centre
Lawson Health Research Institute
August 2017