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

Официальное название

Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score [Срок оценки: 45 Days after the surgery]

Вторичные конечные точки (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 [Срок оценки: 45 Days after the surgery]
• impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE [Срок оценки: 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 [Срок оценки: upt to 5 years after the surgery]
• Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score [Срок оценки: 12 months]
• Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction ) [Срок оценки: 3 years]
• Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction ) [Срок оценки: 5 years]
• Prostate Specific Antigen (PSA) level [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• patient hospitalized for a planned radical prostatectomy

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 30 центров

• 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
• … и ещё 22 центра

Идентификаторы

NCT: NCT04638088 · GCS-ELSAN-0620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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