Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

Hospices Civils de Lyon25 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Service d'Urologie - Clinique St Augustin

Bordeaux, France

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

Lyon, France

Service d'Urologie - Institut Mutualiste Montsouris

Paris, France

Outcomes

Primary Outcomes

Erectile function

Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.

Time frame: 12 months after surgery

Secondary Outcomes

Surgical margins

Time frame: During surgery

Prostate Specific Antigen (PSA)

Time frame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery

Continence

Continence is assessed by the International Prostate Symptom Score (IPSS)

Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery

Tolerance

Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery

Time frame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery

Quality of life

Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores

Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery

Incremental cost-effectiveness ratio

Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment

Time frame: 60 months afet surgery