Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

NCT ID: NCT02784314

Last Updated: 2017-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-08-31

Brief Summary

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In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic-Assisted Radical Prostatectomy

Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System

Group Type EXPERIMENTAL

Robotic-Assisted Radical Prostatectomy

Intervention Type PROCEDURE

Laparoscopic Radical Prostatectomy

Standard laparoscopic Radical Prostatectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic Radical Prostatectomy

Intervention Type PROCEDURE

Interventions

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Robotic-Assisted Radical Prostatectomy

Intervention Type PROCEDURE

Laparoscopic Radical Prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Localized prostate cancer
* Gleason grade ≤ 3 + 4
* PSA \< 15 ng / mL
* Stage ≤ T2b
* Eligible to receive laparoscopic radical prostatectomy
* Candidate bilateral or unilateral erectile preservation

Exclusion Criteria

* Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
* Presenting erectile dysfunction (IIEF \< 22)
* Past history of urinary incontinence (\> grade 1 WHO)
* Body mass index \> 30
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'Urologie - Clinique St Augustin

Bordeaux, , France

Site Status

Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon

Lyon, , France

Site Status

Service d'Urologie - Institut Mutualiste Montsouris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2009.587

Identifier Type: -

Identifier Source: org_study_id

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