EMUPRO: Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| robot-assisted laparoscopy radical prostatectomy performed by robot-assisted laparoscopy |
Other: assessment of urinary function and erectil function before and after prostatectomy
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
|
| conventional laparoscopy radical prostatectomy performed by conventional laparoscopy |
Other: assessment of urinary function and erectil function before and after prostatectomy
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
|
| laparotomy radical prostatectomy performed by laparotomy |
Other: assessment of urinary function and erectil function before and after prostatectomy
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
|
Outcome Measures
Primary Outcome Measures
- Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score [45 Days after the surgery]
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)
Secondary Outcome Measures
- 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 [45 Days after the surgery]
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)
- 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 [12 months]
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
- 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 [up to 5 years]
measures of the level of PSA in a man's blood
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Esquirol Saint Hilaire | Agen | France | 47000 | |
| 2 | Clinique Rhône Durance | Avignon | France | 84000 | |
| 3 | Hôpital Privé La Châtaigneraie | Beaumont | France | 63110 | |
| 4 | Clinique St Vincent | Besançon | France | 25000 | |
| 5 | Clinique de Saint Augustin | Bordeaux | France | 33074 | |
| 6 | Clinique Keraudren - CHPB | Brest | France | 29200 | |
| 7 | Centre Médico-Chirurgical Les Cèdres | Brive-la-Gaillarde | France | 19100 | |
| 8 | Polyclinique Médipôle Saint-Roch | Cabestany | France | 6633 | |
| 9 | Polyclinique Montréal | Carcassonne | France | 11000 | |
| 10 | Pôle Santé République | Clermont-Ferrand | France | 63100 | |
| 11 | Hôpital Privé Saint-François | Desertines | France | 03630 | |
| 12 | Pôle Santé Sud | Le Mans | France | 72000 | |
| 13 | Clinique Emailleurs-Colombier | Limoges | France | 87000 | |
| 14 | Polyclinique de Limoges | Limoges | France | 87000 | |
| 15 | Clinique Claude Bernard | Metz | France | 57070 | |
| 16 | Polyclinique de Gentilly | Nancy | France | 54100 | |
| 17 | Clinique Saint-Augustin | Nantes | France | 44000 | |
| 18 | Polyclinique Grand Sud | Nîmes | France | 30900 | |
| 19 | Polyclinique Les Fleurs | Ollioules | France | 83190 | |
| 20 | Polyclinique de Poitiers | Poitiers | France | 86000 | |
| 21 | Clinique Guillaume De Varye | Saint-Doulchard | France | 18230 | |
| 22 | Centre clinical | Soyaux | France | 16800 | |
| 23 | Clinique de l'Estrée | Stains | France | 93240 | |
| 24 | Clinique Ambroise Paré | Toulouse | France | 31082 | |
| 25 | Polyclinique Vauban | Valenciennes | France | 59300 | |
| 26 | Hôpital privé Océane | Vannes | France | 56000 |
Sponsors and Collaborators
- Elsan
Investigators
- Study Director: Shahnaz KLOUCHE, MD, Elsan
- Principal Investigator: Pierre-Thierry PIECHAUD, MD, Elsan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GCS-ELSAN-0620