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

NCT ID: NCT04638088

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-08

Study Completion Date

2030-04-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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robot-assisted laparoscopy

radical prostatectomy performed by robot-assisted laparoscopy

assessment of urinary function and erectil function before and after prostatectomy

Intervention Type OTHER

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

assessment of urinary function and erectil function before and after prostatectomy

Intervention Type OTHER

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

assessment of urinary function and erectil function before and after prostatectomy

Intervention Type OTHER

assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Elsan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahnaz KLOUCHE, MD

Role: STUDY_DIRECTOR

Elsan

Pierre-Thierry PIECHAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Elsan

Locations

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Clinique Esquirol Saint Hilaire

Agen, , France

Site Status RECRUITING

Clinique Rhône Durance

Avignon, , France

Site Status COMPLETED

Hôpital Privé La Châtaigneraie

Beaumont, , France

Site Status COMPLETED

Clinique St Vincent

Besançon, , France

Site Status COMPLETED

Polyclinique de Franche Comté

Besançon, , France

Site Status COMPLETED

Clinique de Saint Augustin

Bordeaux, , France

Site Status COMPLETED

Clinique Keraudren - CHPB

Brest, , France

Site Status RECRUITING

Centre Médico-Chirurgical Les Cèdres

Brive-la-Gaillarde, , France

Site Status RECRUITING

Polyclinique Médipôle Saint-Roch

Cabestany, , France

Site Status COMPLETED

Polyclinique du Parc

Caen, , France

Site Status COMPLETED

Polyclinique Montréal

Carcassonne, , France

Site Status RECRUITING

Pôle Santé République

Clermont-Ferrand, , France

Site Status RECRUITING

Hôpital Privé Saint-François

Désertines, , France

Site Status WITHDRAWN

Clinique Cap-d'Or

La Seyne-sur-Mer, , France

Site Status COMPLETED

Pôle Santé Sud

Le Mans, , France

Site Status COMPLETED

Clinique Emailleurs-Colombier

Limoges, , France

Site Status RECRUITING

Polyclinique de Limoges

Limoges, , France

Site Status COMPLETED

Clinique Claude Bernard

Metz, , France

Site Status WITHDRAWN

Polyclinique de Gentilly

Nancy, , France

Site Status COMPLETED

Clinique Saint-Augustin

Nantes, , France

Site Status COMPLETED

Polyclinique Grand Sud

Nîmes, , France

Site Status COMPLETED

Polyclinique Les Fleurs

Ollioules, , France

Site Status COMPLETED

Polyclinique de Poitiers

Poitiers, , France

Site Status RECRUITING

Clinique du Renaison

Roanne, , France

Site Status RECRUITING

Clinique Guillaume De Varye

Saint-Doulchard, , France

Site Status COMPLETED

Centre clinical

Soyaux, , France

Site Status COMPLETED

Clinique de l'Estrée

Stains, , France

Site Status COMPLETED

Clinique Ambroise Paré

Toulouse, , France

Site Status RECRUITING

Polyclinique Vauban

Valenciennes, , France

Site Status COMPLETED

Hôpital privé Océane

Vannes, , France

Site Status COMPLETED

Countries

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France

Central Contacts

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Shahnaz KLOUCHE, MD

Role: CONTACT

[email protected]
00331 58 56 41 71

Facility Contacts

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Xavier CUVILLIER, MD

Role: primary

[email protected]
00335 53 69 27 15

Maxime THOULOUZAN, MD

Role: primary

[email protected]
00332 98 34 29 42

Pascal BOURNEL, MD

Role: primary

[email protected]

Frédéric VAVDIN, MD

Role: primary

[email protected]

Arnaud SCHOENIG, MD

Role: primary

[email protected]
00334 73 99 49 49

Nicolas LESAUX, MD

Role: primary

[email protected]

Christian PEYRET, MD

Role: primary

[email protected]

Thierry BETHMONT, MD

Role: primary

[email protected]

Frédéric JONCA, MD

Role: primary

[email protected]

Other Identifiers

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GCS-ELSAN-0620

Identifier Type: -

Identifier Source: org_study_id

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