Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: assessment of urinary function and erectil function before and after prostatectomy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
Overview
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.
Detailed 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.
Interventions
- Other 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
Primary outcome measures
- Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score [Time frame: 45 Days after the surgery]
Secondary outcome measures (7)
- 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 [Time frame: 45 Days after the surgery]
- 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]
- 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]
- Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score [Time frame: 12 months]
- Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction ) [Time frame: 3 years]
- Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction ) [Time frame: 5 years]
- Prostate Specific Antigen (PSA) level [Time frame: up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 30 centers
- Clinique Esquirol Saint Hilaire — Agen
- Clinique Rhône Durance — Avignon
- Hôpital Privé La Châtaigneraie — Beaumont
- Clinique St Vincent — Besançon
- Polyclinique de Franche Comté — Besançon
- Clinique de Saint Augustin — Bordeaux
- Clinique Keraudren - CHPB — Brest
- Centre Médico-Chirurgical Les Cèdres — Brive-la-Gaillarde
- … and 22 more centers
Identifiers
NCT: NCT04638088 · GCS-ELSAN-0620