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

April 20, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Completed
        • Clinique St Vincent
      • Besançon, France, 25000
        • Completed
        • Polyclinique de Franche Comté
      • 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
        • Completed
        • Polyclinique du Parc
      • Carcassonne, France, 11000
        • Recruiting
        • Polyclinique Montréal
        • Contact:
        • Principal Investigator:
          • Frédéric VAVDIN, MD
      • Clermont-Ferrand, France, 63100
        • Recruiting
        • Pole Santé République
        • Contact:
        • Principal Investigator:
          • Arnaud SCHOENIG, MD
      • Désertines, France, 03630
        • Withdrawn
        • Hôpital Privé Saint-François
      • La Seyne-sur-Mer, France, 83500
        • Completed
        • Clinique Cap-d'Or
      • Le Mans, France, 72000
        • Completed
        • Pôle Santé Sud
      • Limoges, France, 87000
        • Recruiting
        • Clinique Emailleurs-Colombier
        • Contact:
        • Principal Investigator:
          • Nicolas LESAUX, MD
      • Limoges, France, 87000
        • Completed
        • Polyclinique de Limoges
      • Metz, France, 57070
        • Withdrawn
        • Clinique Claude Bernard
      • Nancy, France, 54100
        • Completed
        • Polyclinique de Gentilly
      • Nantes, France, 44000
        • Completed
        • Clinique Saint-Augustin
      • 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
        • Recruiting
        • Clinique du Renaison
        • Contact:
        • Principal Investigator:
          • Thierry BETHMONT, MD
      • Saint-Doulchard, France, 18230
        • Completed
        • Clinique Guillaume De Varye
      • Soyaux, France, 16800
        • Completed
        • Centre Clinical
      • Stains, France, 93240
        • Completed
        • Clinique de l'Estrée
      • Toulouse, France, 31082
        • Recruiting
        • Clinique Ambroise Pare
        • Contact:
        • Principal Investigator:
          • Frédéric JONCA, MD
      • Valenciennes, France, 59300
        • Completed
        • Polyclinique Vauban
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elsan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings