Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

Study Overview
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Brief Summary
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Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Detailed Description
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Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

Official Title
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Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: assessment of urinary function and erectil function before and after prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient hospitalized for a planned radical prostatectomy Exclusion Criteria: Consent refusal from the patient Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique) Absence of a French Health Care Insurance coverage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| robot-assisted laparoscopy<br>radical prostatectomy performed by robot-assisted laparoscopy | Other: assessment of urinary function and erectil function before and after prostatectomy<br>* assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete<br>|
| conventional laparoscopy<br>radical prostatectomy performed by conventional laparoscopy | Other: assessment of urinary function and erectil function before and after prostatectomy<br>* assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete<br>|
| laparotomy<br>radical prostatectomy performed by laparotomy | Other: assessment of urinary function and erectil function before and after prostatectomy<br>* assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score | Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite) | 45 Days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score | impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy on the erectile function assessed by he EPIC 50 score (Expanded Prostate Cancer Index Composite) | 45 Days after the surgery | 
| impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE |  | up to 5 years after surgery | 
| impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score |  | upt to 5 years after the surgery | 
| Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score | Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score | 12 months | 
| Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction ) |  | 3 years | 
| Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction ) |  | 5 years | 
| Prostate Specific Antigen (PSA) level | measures of the level of PSA in a man's blood | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparotomy, robot-assisted laparoscopy, conventional laparoscopy, prostatectomy