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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score — 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)

Trial sites (30)

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