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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorElsan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

patient hospitalized for a planned radical prostatectomy

Disqualifiers

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 population

patient hospitalized for a planned radical prostactectomy .

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • assessment of urinary function and erectil function before and after prostatectomy

    Other intervention

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

Treatment groups

2,000 Participants
are divided into 3 treatment groups
Group A: robot-assisted laparoscopy1 intervention
Group B: conventional laparoscopy1 intervention
Group C: laparotomy1 intervention

Trial outcomes

Primary outcomes

1

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

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)

Time frame
45 Days after the surgery

Secondary outcomes

1

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

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)

Time frame
45 Days after the surgery
2

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
3

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
4

Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score

Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score

Time frame
12 months

Other outcomes

Sponsors and contacts

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