NCT04638088 Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
| NCT ID | NCT04638088 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elsan |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2025-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2021-03-08 with a primary completion date of 2025-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shahnaz KLOUCHE, MD
STUDY DIRECTOR
Elsan
Frequently Asked Questions
Who can join the NCT04638088 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04638088 currently recruiting?
Yes, NCT04638088 is actively recruiting participants. Contact the research team at klouche@elsan.care for enrollment information.
Where is the NCT04638088 trial being conducted?
This trial is being conducted at Agen, France, Avignon, France, Beaumont, France, Besançon, France and 11 additional locations.
Who is sponsoring the NCT04638088 clinical trial?
NCT04638088 is sponsored by Elsan. The principal investigator is Shahnaz KLOUCHE, MD at Elsan. The trial plans to enroll 2,000 participants.
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