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

September 20, 2023 updated by: Elsan

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Agen, France, 47000
        • Recruiting
        • Clinique Esquirol Saint Hilaire
        • Contact:
        • Principal Investigator:
          • Xavier CUVILLIER, MD
      • Avignon, France, 84000
        • Completed
        • Clinique Rhône Durance
      • Beaumont, France, 63110
        • Completed
        • Hôpital Privé La Châtaigneraie
      • Besançon, France, 25000
        • Recruiting
        • Polyclinique de Franche Comté
        • Contact:
        • Principal Investigator:
          • PALMERO Xavier, MD
      • Besançon, France, 25000
        • Completed
        • Clinique St Vincent
      • Bordeaux, France, 33074
        • Completed
        • Clinique de Saint Augustin
      • Brest, France, 29200
      • Brive-la-Gaillarde, France, 19100
        • Recruiting
        • Centre Médico-Chirurgical Les Cèdres
        • Contact:
        • Principal Investigator:
          • Pascal BOURNEL, MD
      • Cabestany, France, 6633
        • Completed
        • Polyclinique Médipôle Saint-Roch
      • Caen, France, 14000
        • Recruiting
        • Polyclinique du Parc
        • Contact:
        • Principal Investigator:
          • Jean-Georges GUERIN WALLNER, MD
      • Carcassonne, France, 11000
        • Recruiting
        • Polyclinique Montréal
        • Contact:
        • Principal Investigator:
          • Frédéric VAVDIN, MD
      • Clermont-Ferrand, France, 63100
        • Recruiting
        • Pôle Santé République
        • Contact:
        • Principal Investigator:
          • Arnaud SCHOENIG, MD
      • Desertines, France, 03630
        • Not yet recruiting
        • Hôpital Privé Saint-François
        • Contact:
        • Principal Investigator:
          • Olivier BERDUGO, MD
      • La Seyne-sur-Mer, France, 83500
        • Recruiting
        • Clinique Cap-d'Or
        • Contact:
        • Principal Investigator:
          • Christophe LEGON, MD
      • Le Mans, France, 72000
        • Recruiting
        • Pôle Santé Sud
        • Contact:
        • Principal Investigator:
          • Olivier BELAS, MD
      • Limoges, France, 87000
        • Recruiting
        • Polyclinique de Limoges
        • Contact:
          • Franck SALOME, MD
          • Phone Number: 00335 55 45 44 05
        • Principal Investigator:
          • Franck SALOME, MD
      • Limoges, France, 87000
        • Recruiting
        • Clinique Emailleurs-Colombier
        • Contact:
        • Principal Investigator:
          • Nicolas LESAUX, MD
      • Metz, France, 57070
        • Not yet recruiting
        • Clinique Claude Bernard
        • Contact:
        • Principal Investigator:
          • Bogdan SERBANESCU, MD
      • Nancy, France, 54100
        • Recruiting
        • Polyclinique de Gentilly
        • Contact:
        • Principal Investigator:
          • Nicolas HUBERT, MD
      • Nantes, France, 44000
        • Recruiting
        • Clinique Saint-Augustin
        • Contact:
        • Principal Investigator:
          • Quentin Come LE CLERC, MD
      • Nîmes, France, 30900
        • Completed
        • Polyclinique Grand Sud
      • Ollioules, France, 83190
        • Completed
        • Polyclinique Les Fleurs
      • Poitiers, France, 86000
        • Recruiting
        • Polyclinique de Poitiers
        • Contact:
        • Principal Investigator:
          • Christian PEYRET, MD
      • Roanne, France, 42300
        • Not yet recruiting
        • Clinique du Renaison
        • Contact:
        • Principal Investigator:
          • Thierry BETHMONT, MD
      • Saint-Doulchard, France, 18230
        • Recruiting
        • Clinique Guillaume De Varye
        • Contact:
        • Principal Investigator:
          • Florent MAILLARD, MD
      • Soyaux, France, 16800
        • Recruiting
        • Centre Clinical
        • Contact:
        • Principal Investigator:
          • Serge Gabriele, md
      • Stains, France, 93240
        • Completed
        • Clinique de l'Estrée
      • Toulouse, France, 31082
        • Not yet recruiting
        • Clinique Ambroise Pare
        • Contact:
        • Principal Investigator:
          • Frédéric JONCA, MD
      • Valenciennes, France, 59300
        • Recruiting
        • Polyclinique Vauban
        • Contact:
        • Principal Investigator:
          • Tawfik WAHIDY, MD
      • Vannes, France, 56000
        • Completed
        • Hôpital Privé Océane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patient hospitalized for a planned radical prostactectomy .

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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
Time Frame: 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)
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
Time Frame: 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)
45 Days after the surgery
impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
Time Frame: up to 5 years after surgery
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
Time Frame: upt to 5 years after the surgery
upt to 5 years after the surgery
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Time Frame: 12 months
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 )
Time Frame: 3 years
3 years
Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )
Time Frame: 5 years
5 years
Prostate Specific Antigen (PSA) level
Time Frame: up to 5 years
measures of the level of PSA in a man's blood
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Investigators

  • Study Director: Shahnaz KLOUCHE, MD, Elsan
  • Principal Investigator: Pierre-Thierry PIECHAUD, MD, Elsan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

March 25, 2024

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCS-ELSAN-0620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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