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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01577836
Collaborator
(none)
90
3
117.2
30
0.3

Study Details

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
    Actual Study Start Date :
    Nov 26, 2012
    Actual Primary Completion Date :
    Jun 4, 2018
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Robotic assistance, Nîmes

    The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes.

    Laparotomy, Marseilles

    The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.

    Outcome Measures

    Primary Outcome Measures

    1. Overall cost (€) of patient care [60 months]

      Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 5 years. All medical resources consumed will be evaluated during the first 5 years after surgery.

    Secondary Outcome Measures

    1. Cost (€) of surgery via micro-costing [Day 1]

      All human and material resources necessary for carrying out a prostatectomy will be evaluated.

    2. Change in erectile function [baseline to 1 month]

      the International Index of Erectile Function (IIEF-15) will be used.

    3. Change in erectile function [baseline to 6 months]

      the International Index of Erectile Function (IIEF-15) will be used.

    4. Change in erectile function [baseline to 12 months]

      the International Index of Erectile Function (IIEF-15) will be used.

    5. Change in erectile function [baseline to 24 months]

      the International Index of Erectile Function (IIEF-15) will be used.

    6. the % of positive margins after resection [baseline (Day 1)]

    7. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [1 month]

    8. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [6 months]

    9. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [12 months]

    10. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [24 months]

    11. Change in function as estimated by the PR25 questionnaire [baseline to 1 month]

    12. Change in function as estimated by the PR25 questionnaire [baseline to 6 months]

    13. Change in function as estimated by the PR25 questionnaire [baseline to 12 months]

    14. Change in function as estimated by the PR25 questionnaire [baseline to 24 months]

    15. Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 1 month]

    16. Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 6 months]

    17. Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 12 months]

    18. Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 24 months]

    19. Presence/absence of complications (Clavien) [1 month]

      The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)

    20. Presence/absence of complications (Clavien) [24 months]

      The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)

    21. Presence/absence of complications (Pentafecta) [1 month]

      The Pentafecta classification will be used.

    22. Presence/absence of complications (Pentafecta) [24 months]

      The Pentafecta classification will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The patient must have given his informed and signed consent

    • The patient must be insured or beneficiary of a health insurance plan

    • The patient is available for 24 months of follow up

    • Patient has localised prostate cancer

    • Patient is eligible for radical prostatectomy

    Exclusion Criteria:
    • The patient is participating in another study

    • The patient is in an exclusion period determined by a previous study

    • The patient is under judicial protection, under tutorship or curatorship

    • The patient refuses to sign the consent

    • It is impossible to correctly inform the patient

    • Patient has a contraindication for a treatment necessary for this study

    • Patients with psychiatric disorders

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 APHM - Hôpital de la Conception Marseille Cedex 5 France 13385
    2 Clinique Beau Soleil Montpellier France 34070
    3 CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Principal Investigator: Stéphane Droupy, MD PhD, Centre Hospitalier Universitaire de Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT01577836
    Other Study ID Numbers:
    • AOI/2011/SD-03
    • 2011-A01385-36
    First Posted:
    Apr 16, 2012
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Aug 1, 2021
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2022