Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Обзор

The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post-operative complications. Researchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure. Participants will: * Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests. * Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months * Keep a diary to record procedures and treatments related to the care provided

Вмешательства

• Процедура radical prostatectomy
  Robot-assisted

Первичные конечные точки

• Early complication of robot-assisted prostatectomy [Срок оценки: From the day of surgery to 8 days post-operative]

Вторичные конечные точки (12)

• Conversion rate from outpatient to full hospitalisation (Outpatient failure rate) [Срок оценки: Day of surgery]
• Rate of cancellation of outpatient treatment by the patient or his private environment [Срок оценки: From enrollment to the day of surgery]
• Rate of patients readmitted to hospital, either as emergencies or in the department [Срок оценки: From hospital discharge to 8 days post-operative.]
• Association of each early complication with treatment (outpatient or inpatient) [Срок оценки: From hospitalisation discharge to 8 days post-operative]
• Rate of patients having had at least one complication secondary to surgery [Срок оценки: From 8 days to 45 days post-operative]
• Rate of patients with at least one complication secondary to surgery [Срок оценки: From 45 days to 6 months post-operative]
• Patient's pre-operative stress/anxiety levels [Срок оценки: 3 days before surgery, day of surgery and 2 days post-operative]
• Patient satisfaction level [Срок оценки: 2 days and 45 days post-operative]
• Duration of surgery [Срок оценки: Day of surgery]
• Blood loss [Срок оценки: Day of surgery]
• Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery [Срок оценки: Baseline and 45 days post-operative]
• Evolution of urinary continence between 45 days and 6 months post-operatively and evolution of urinary function pre-operatively, at 45 days, at 6 months. [Срок оценки: Baseline and 45 days, 6 months after surgery]

Критерии участия

Критерии включения

• Male, aged 18 and over
• Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)
• Patient eligible for outpatient treatment :

• The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
• The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)
• The patient has access to telephone communication facilities.
• The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.
• The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.
• Participant affiliated to or benefiting from a social security scheme
• The participant has been informed and has given his/her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).

Критерии исключения

• Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
• Patient participating in ongoing research or in a period of exclusion at the time of inclusion
• Refusal or inability to comply with the study protocol for any reason whatsoever
• Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 12 центров

• Clinique Rhône Durance — Avignon
• Clinique St Vincent — Besançon
• Clinique St Augustin — Bordeaux
• Polyclinique Médipôle St-Roch — Cabestany
• Polyclinique du Parc — Caen
• Pole Sante Sud-CMCM — Le Mans
• Hôpital Privé Nancy Lorraine — Nancy
• Polyclinique Les Fleurs — Ollioules
• … и ещё 4 центра

Идентификаторы

NCT: NCT06822452 · PROSTAMBU · 2024-A01745-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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