Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
EMUPRO
1 other identifier
observational
2,000
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
ExpectedApril 21, 2026
April 1, 2026
4.4 years
November 16, 2020
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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 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
Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )
3 years
- +2 more secondary outcomes
Study Arms (3)
robot-assisted laparoscopy
radical prostatectomy performed by robot-assisted laparoscopy
conventional laparoscopy
radical prostatectomy performed by conventional laparoscopy
laparotomy
radical prostatectomy performed by laparotomy
Interventions
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
Eligibility Criteria
patient hospitalized for a planned radical prostactectomy .
You may qualify if:
- patient hospitalized for a planned radical prostatectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elsanlead
Study Sites (30)
Clinique Esquirol Saint Hilaire
Agen, 47000, France
Clinique Rhône Durance
Avignon, 84000, France
Hôpital Privé La Châtaigneraie
Beaumont, 63110, France
Clinique St Vincent
Besançon, 25000, France
Polyclinique de Franche Comté
Besançon, 25000, France
Clinique de Saint Augustin
Bordeaux, 33074, France
Clinique Keraudren - CHPB
Brest, 29200, France
Centre Médico-Chirurgical Les Cèdres
Brive-la-Gaillarde, 19100, France
Polyclinique Médipôle Saint-Roch
Cabestany, 6633, France
Polyclinique du Parc
Caen, 14000, France
Polyclinique Montréal
Carcassonne, 11000, France
Pôle Santé République
Clermont-Ferrand, 63100, France
Hôpital Privé Saint-François
Désertines, 03630, France
Clinique Cap-d'Or
La Seyne-sur-Mer, 83500, France
Pôle Santé Sud
Le Mans, 72000, France
Clinique Emailleurs-Colombier
Limoges, 87000, France
Polyclinique de Limoges
Limoges, 87000, France
Clinique Claude Bernard
Metz, 57070, France
Polyclinique de Gentilly
Nancy, 54100, France
Clinique Saint-Augustin
Nantes, 44000, France
Polyclinique Grand Sud
Nîmes, 30900, France
Polyclinique Les Fleurs
Ollioules, 83190, France
Polyclinique de Poitiers
Poitiers, 86000, France
Clinique du Renaison
Roanne, 42300, France
Clinique Guillaume De Varye
Saint-Doulchard, 18230, France
Centre clinical
Soyaux, 16800, France
Clinique de l'Estrée
Stains, 93240, France
Clinique Ambroise Paré
Toulouse, 31082, France
Polyclinique Vauban
Valenciennes, 59300, France
Hôpital privé Océane
Vannes, 56000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shahnaz KLOUCHE, MD
Elsan
- PRINCIPAL INVESTIGATOR
Pierre-Thierry PIECHAUD, MD
Elsan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 20, 2020
Study Start
March 8, 2021
Primary Completion
July 21, 2025
Study Completion (Estimated)
April 30, 2030
Last Updated
April 21, 2026
Record last verified: 2026-04