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

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT01577836
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Study Start: 2012-11-26
• Primary Completion: 2018-06-04
• Study Completion: 2021-03-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (3)

APHM - Hôpital de la Conception; 🇫🇷 Marseille Cedex 5, France

Clinique Beau Soleil; 🇫🇷 Montpellier, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France