Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robot-assisted laparoscopy | radical prostatectomy performed by robot-assisted laparoscopy |
| |
| conventional laparoscopy | radical prostatectomy performed by conventional laparoscopy |
| |
| laparotomy | radical prostatectomy performed by laparotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of urinary function and erectil function before and after prostatectomy | Other | assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patient hospitalized for a planned radical prostactectomy .
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahnaz KLOUCHE, MD | Contact | 00331 58 56 41 71 | klouche@elsan.care |
| Name | Affiliation | Role |
|---|---|---|
| Shahnaz KLOUCHE, MD | Elsan | Study Director |
| Pierre-Thierry PIECHAUD, MD | Elsan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Esquirol Saint Hilaire | Recruiting | Agen | 47000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Clinique Rhône Durance | Completed | Avignon | 84000 | France |
| Hôpital Privé La Châtaigneraie | Completed | Beaumont | 63110 | France |
| Clinique St Vincent | Completed | Besançon | 25000 | France |
| Polyclinique de Franche Comté | Completed | Besançon | 25000 | France |
| Clinique de Saint Augustin | Completed | Bordeaux | 33074 | France |
| Clinique Keraudren - CHPB | Recruiting | Brest | 29200 | France |
|
| Centre Médico-Chirurgical Les Cèdres | Recruiting | Brive-la-Gaillarde | 19100 | France |
|
| Polyclinique Médipôle Saint-Roch | Completed | Cabestany | 6633 | France |
| Polyclinique du Parc | Completed | Caen | 14000 | France |
| Polyclinique Montréal | Recruiting | Carcassonne | 11000 | France |
|
| Pôle Santé République | Recruiting | Clermont-Ferrand | 63100 | France |
|
| Hôpital Privé Saint-François | Withdrawn | Désertines | 03630 | France |
| Clinique Cap-d'Or | Completed | La Seyne-sur-Mer | 83500 | France |
| Pôle Santé Sud | Completed | Le Mans | 72000 | France |
| Clinique Emailleurs-Colombier | Recruiting | Limoges | 87000 | France |
|
| Polyclinique de Limoges | Completed | Limoges | 87000 | France |
| Clinique Claude Bernard | Withdrawn | Metz | 57070 | France |
| Polyclinique de Gentilly | Completed | Nancy | 54100 | France |
| Clinique Saint-Augustin | Completed | Nantes | 44000 | France |
| Polyclinique Grand Sud | Completed | Nîmes | 30900 | France |
| Polyclinique Les Fleurs | Completed | Ollioules | 83190 | France |
| Polyclinique de Poitiers | Recruiting | Poitiers | 86000 | France |
|
| Clinique du Renaison | Recruiting | Roanne | 42300 | France |
|
| Clinique Guillaume De Varye | Completed | Saint-Doulchard | 18230 | France |
| Centre clinical | Completed | Soyaux | 16800 | France |
| Clinique de l'Estrée | Completed | Stains | 93240 | France |
| Clinique Ambroise Paré | Recruiting | Toulouse | 31082 | France |
|
| Polyclinique Vauban | Completed | Valenciennes | 59300 | France |
| Hôpital privé Océane | Completed | Vannes | 56000 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided