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

Centre Hospitalier Universitaire de Nīmes90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

Robot-assisted radical prostatectomyPROCEDURE

Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S

Radical prostatectomy via laparotomyPROCEDURE

Classic radical prostatectomy via open retropubic approach

Eligibility

Sex: MALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

APHM - Hôpital de la Conception

Marseille, France

Clinique Beau Soleil

Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Overall cost (€) of patient care

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.

Time frame: 60 months

Secondary Outcomes

Cost (€) of surgery via micro-costing

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

Time frame: Day 1

Change in erectile function

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

Time frame: baseline to 1 month

Change in erectile function

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

Time frame: baseline to 6 months

Change in erectile function

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

Time frame: baseline to 12 months

Change in erectile function

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

Time frame: baseline to 24 months

the % of positive margins after resection

Time frame: baseline (Day 1)

presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)

Time frame: 1 month

Data from ClinicalTrials.gov

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