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Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

NCT02784314 · Hospices Civils de Lyon · Updated 5 June 2017

What is being tested
Robotic-Assisted Radical Prostatectomy; Laparoscopic Radical Prostatectomy
For
Prostate Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 40 years to 70 years. About 25 people. The full rules are on the registry page.
Where
France (3 sites)
When
Starts or started May 2010, ends Aug 2016. Registered 27 May 2016.
Results
None posted yet.

In the researchers' words

In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).
ClinicalTrials.gov, NCT02784314

Sites

  • Service d'Urologie - Clinique St AugustinBordeaux, France
  • Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de LyonLyon, France
  • Service d'Urologie - Institut Mutualiste MontsourisParis, France