CompletedNot Applicable

Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

France25 participantsStarted 2010-05

Plain-language summary

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).

Who can participate

Age range40 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Localized prostate cancer * Gleason grade ≤ 3 + 4 * PSA \< 15 ng / mL * Stage ≤ T2b * Eligible to receive laparoscopic radical prostatectomy * Candidate bilateral or unilateral erectile preservation Exclusion Criteria: * Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3 * Presenting erectile dysfunction (IIEF \< 22) * Past history of urinary incontinence (\> grade 1 WHO) * Body mass index \> 30

What they're measuring

Erectile function

Timeframe: 12 months after surgery

Trial details

NCT IDNCT02784314

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

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