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

Prostate Cancer Clinical Trial

— EMUPRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638088
• Other study ID #: GCS-ELSAN-0620
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2029

Study information

• Verified date: June 2024
• Source: Elsan
• Contact: Shahnaz KLOUCHE, MD
• Phone: 00331 58 56 41 71
• Email: klouche[@]elsan.care
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2029
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Clinique Esquirol Saint Hilaire	Agen
France	Clinique Rhône Durance	Avignon
France	Hôpital Privé La Châtaigneraie	Beaumont
France	Clinique St Vincent	Besançon
France	Polyclinique de Franche Comté	Besançon
France	Clinique de Saint Augustin	Bordeaux
France	Clinique Keraudren - CHPB	Brest
France	Centre Médico-Chirurgical Les Cèdres	Brive-la-Gaillarde
France	Polyclinique Médipôle Saint-Roch	Cabestany
France	Polyclinique du Parc	Caen
France	Polyclinique Montréal	Carcassonne
France	Pôle Santé République	Clermont-Ferrand
France	Hôpital Privé Saint-François	Desertines
France	Clinique Cap-d'Or	La Seyne-sur-Mer
France	Pôle Santé Sud	Le Mans
France	Clinique Emailleurs-Colombier	Limoges
France	Polyclinique de Limoges	Limoges
France	Clinique Claude Bernard	Metz
France	Polyclinique de Gentilly	Nancy
France	Clinique Saint-Augustin	Nantes
France	Polyclinique Grand Sud	Nîmes
France	Polyclinique Les Fleurs	Ollioules
France	Polyclinique de Poitiers	Poitiers
France	Clinique du Renaison	Roanne
France	Clinique Guillaume De Varye	Saint-Doulchard
France	Centre clinical	Soyaux
France	Clinique de l'Estrée	Stains
France	Clinique Ambroise Paré	Toulouse
France	Polyclinique Vauban	Valenciennes
France	Hôpital privé Océane	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE		up to 5 years after surgery
Secondary	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
Secondary	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
Secondary	Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )		3 years
Secondary	Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )		5 years
Secondary	Prostate Specific Antigen (PSA) level	measures of the level of PSA in a man's blood	up to 5 years