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

Elsan

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: assessment of urinary function and erectil function before and after prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04638088

GCS-ELSAN-0620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 3 patient groups

robot-assisted laparoscopy

Description:

radical prostatectomy performed by robot-assisted laparoscopy

Treatment:

Other: assessment of urinary function and erectil function before and after prostatectomy

conventional laparoscopy

Description:

radical prostatectomy performed by conventional laparoscopy

Treatment:

Other: assessment of urinary function and erectil function before and after prostatectomy

laparotomy

Description:

radical prostatectomy performed by laparotomy

Treatment:

Other: assessment of urinary function and erectil function before and after prostatectomy