Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Laparoscopic Radical Prostatectomy; Procedure: Robotic-Assisted Radical Prostatectomy

• Registration Number: NCT02784314
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-05
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Completion: 2016-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-02
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Radical Prostatectomy	Laparoscopic Radical Prostatectomy	Standard laparoscopic Radical Prostatectomy
Robotic-Assisted Radical Prostatectomy	Robotic-Assisted Radical Prostatectomy	Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System

Primary Outcome Measures

Name	Time	Method
Erectile function	12 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Prostate Specific Antigen (PSA)	Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Continence	Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery	Continence is assessed by the International Prostate Symptom Score (IPSS)
Tolerance	Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery	Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery
Quality of life	Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery	Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores
Incremental cost-effectiveness ratio	60 months afet surgery	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
Surgical margins	During surgery

Trial Locations

Locations (3)

Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon; 🇫🇷 Lyon cedex 03, France

Service d'Urologie - Clinique St Augustin; 🇫🇷 Bordeaux, France

Service d'Urologie - Institut Mutualiste Montsouris; 🇫🇷 Paris, France