Clinical trial NCT01577836: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Radical prostatectomie
Robotic assistance
Laparotomy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 90
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men between the ages of 45 and 75 and who have been diagnosed with localised prostate cancer. The treatment option retained is radical prostatectomy.

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 criteria: 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

Primary outcomes:
measure: Overall cost (€) of patient care
timeFrame: 60 months
Secondary outcomes:
measure: Cost (€) of surgery via micro-costing
timeFrame: Day 1
measure: Change in erectile function
timeFrame: baseline to 1 month
measure: Change in erectile function
timeFrame: baseline to 6 months
measure: Change in erectile function
timeFrame: baseline to 12 months
measure: Change in erectile function
timeFrame: baseline to 24 months
measure: the % of positive margins after resection
timeFrame: baseline (Day 1)
measure: presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
timeFrame: 1 month
measure: presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
timeFrame: 6 months
measure: presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
timeFrame: 12 months
measure: presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
timeFrame: 24 months
measure: Change in function as estimated by the PR25 questionnaire
timeFrame: baseline to 1 month
measure: Change in function as estimated by the PR25 questionnaire
timeFrame: baseline to 6 months
measure: Change in function as estimated by the PR25 questionnaire
timeFrame: baseline to 12 months
measure: Change in function as estimated by the PR25 questionnaire
timeFrame: baseline to 24 months
measure: Change in quality of life as estimated by the QLQC-30 questionnaire
timeFrame: baseline to 1 month
measure: Change in quality of life as estimated by the QLQC-30 questionnaire
timeFrame: baseline to 6 months
measure: Change in quality of life as estimated by the QLQC-30 questionnaire
timeFrame: baseline to 12 months
measure: Change in quality of life as estimated by the QLQC-30 questionnaire
timeFrame: baseline to 24 months
measure: Presence/absence of complications (Clavien)
timeFrame: 1 month
measure: Presence/absence of complications (Clavien)
timeFrame: 24 months
measure: Presence/absence of complications (Pentafecta)
timeFrame: 1 month
measure: Presence/absence of complications (Pentafecta)
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille Cedex 5
country: France
facility: APHM - Hôpital de la Conception
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Stéphane Droupy, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: