RecruitingNCT04638088

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

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


Sponsor

Elsan

Enrollment

2,000 participants

Start Date

Mar 8, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three surgical approaches for removing the prostate (radical prostatectomy) in men with prostate cancer: robotic-assisted laparoscopy (surgery using a robot), traditional laparoscopy (keyhole surgery), and open surgery (traditional incision). The goal is to understand which approach leads to the best outcomes. **You may be eligible if...** - You are scheduled to have a radical prostatectomy (prostate removal) for prostate cancer **You may NOT be eligible if...** - You refuse to give consent to participate - You are in a legally protected category under French health law (e.g., minors, people under guardianship) - You do not have French healthcare insurance coverage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERassessment 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(30)

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

Désertines, 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, France

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NCT04638088


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