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Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
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).
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.
Age
45 - 75 years
Sex
MALE
Healthy Volunteers
No
APHM - Hôpital de la Conception
Marseille, France
Clinique Beau Soleil
Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Start Date
November 26, 2012
Primary Completion Date
June 4, 2018
Completion Date
March 22, 2021
Last Updated
December 12, 2025
90
ACTUAL participants
Robot-assisted radical prostatectomy
PROCEDURE
Radical prostatectomy via laparotomy
PROCEDURE
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
NCT07225946
NCT04868604
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00756665