Know Cancer

or
forgot password

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


N/A
45 Years
75 Years
Open (Enrolling)
Male
Prostatic Neoplasms

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Overall cost (€) of patient care

Outcome Description:

Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 2 years. All medical resources consumed will be evaluated during the first 2 years after surgery.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Stéphane Droupy, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AOI/2011/SD-03

NCT ID:

NCT01577836

Start Date:

October 2012

Completion Date:

September 2015

Related Keywords:

  • Prostatic Neoplasms
  • Radical prostatectomie
  • Robotic assistance
  • Laparotomy
  • Neoplasms
  • Prostatic Neoplasms

Name

Location