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

Prostatic Neoplasms Clinical Trial

— RoboProstate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577836
• Other study ID #: AOI/2011/SD-03
• Secondary ID: 2011-A01385-36
• Status: Completed
• Start date: November 26, 2012
• Est. completion date: March 22, 2021

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 22, 2021
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
France	APHM - Hôpital de la Conception	Marseille Cedex 5
France	Clinique Beau Soleil	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 months
Secondary	Cost (€) of surgery via micro-costing	All human and material resources necessary for carrying out a prostatectomy will be evaluated.	Day 1
Secondary	Change in erectile function	the International Index of Erectile Function (IIEF-15) will be used.	baseline to 1 month
Secondary	Change in erectile function	the International Index of Erectile Function (IIEF-15) will be used.	baseline to 6 months
Secondary	Change in erectile function	the International Index of Erectile Function (IIEF-15) will be used.	baseline to 12 months
Secondary	Change in erectile function	the International Index of Erectile Function (IIEF-15) will be used.	baseline to 24 months
Secondary	the % of positive margins after resection		baseline (Day 1)
Secondary	presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)		1 month
Secondary	presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)		6 months
Secondary	presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)		12 months
Secondary	presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)		24 months
Secondary	Change in function as estimated by the PR25 questionnaire		baseline to 1 month
Secondary	Change in function as estimated by the PR25 questionnaire		baseline to 6 months
Secondary	Change in function as estimated by the PR25 questionnaire		baseline to 12 months
Secondary	Change in function as estimated by the PR25 questionnaire		baseline to 24 months
Secondary	Change in quality of life as estimated by the QLQC-30 questionnaire		baseline to 1 month
Secondary	Change in quality of life as estimated by the QLQC-30 questionnaire		baseline to 6 months
Secondary	Change in quality of life as estimated by the QLQC-30 questionnaire		baseline to 12 months
Secondary	Change in quality of life as estimated by the QLQC-30 questionnaire		baseline to 24 months
Secondary	Presence/absence of complications (Clavien)	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.)	1 month
Secondary	Presence/absence of complications (Clavien)	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.)	24 months
Secondary	Presence/absence of complications (Pentafecta)	The Pentafecta classification will be used.	1 month
Secondary	Presence/absence of complications (Pentafecta)	The Pentafecta classification will be used.	24 months