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

Overview

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

Interventions

• Procedure radical prostatectomy
  Robot-assisted

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 12 centers

• 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
• … and 4 more centers

Identifiers

NCT: NCT06822452 · PROSTAMBU · 2024-A01745-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗