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Spots Global Cancer Trial Database for Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

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Trial Identification

Brief Title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

Official Title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

Study ID: NCT01577836

Interventions

Study Description

Brief Summary: The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy. The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

Detailed Description: The secondary objectives of this research are to compare the following between the two groups: * The actual cost of the surgical prostatectomy. * Erectile function at 0, 1, 6, 12 and 24 * Oncological results at 1, 6, 12 and 24 months. * Functional results at 0, 1, 6, 12 and 24 months. * Quality of life at 0, 1, 6, 12 and 24 months. * Complication rates at 1 and 24 months.

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

APHM - Hôpital de la Conception, Marseille Cedex 5, , France

Clinique Beau Soleil, Montpellier, , France

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes Cedex 09, , France

Contact Details

Name: Stéphane Droupy, MD PhD

Affiliation: Centre Hospitalier Universitaire de Nîmes

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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