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Recruiting Not applicable

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

NCT06822452 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2024-12-30
Last updated
2025-07-08

Condition(s) studied

Prostate Cancer SurgeryAmbulatory CareOutpatient Surgery

Investigational drug(s) / intervention(s)

radical prostatectomy

radical prostatectomy: Robot-assisted

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 : 1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation. 2. 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) 3. The patient has access to telephone communication facilities. 4. 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. 5. 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.

Primary outcome measure(s)

  • Early complication of robot-assisted prostatectomy — From the day of surgery to 8 days post-operative
    The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : * Bleeding from trocar incision scars or surgical excision scars * Urinary leakage around the catheter * Retention due to bladder catheter clotting * Loss of bladder catheter * Signs of internal haemorrhage (within 24 hours) * Signs of biological deglobulation * Intestinal obstruction syndrome * Signs of urinary fistula * Infectious signs : fever \> 38°, chills * Thromboembolicaccidents * Nosocomial infections * Falls

Trial sites (12)

FacilityCityRegionStatus
Clinique Rhône Durance Avignon France Not Yet Recruiting
Clinique St Vincent Besançon France Recruiting
Clinique St Augustin Bordeaux France Recruiting
Polyclinique Médipôle St-Roch Cabestany France Recruiting
Polyclinique du Parc Caen France Not Yet Recruiting
Pole Sante Sud-CMCM Le Mans France Recruiting
Hôpital Privé Nancy Lorraine Nancy France Not Yet Recruiting
Polyclinique Les Fleurs Ollioules France Recruiting
Polyclinique Santé Atlantique Saint-Herblain France Not Yet Recruiting
Clinique Belledonne Saint-Martin-d'Hères France Recruiting
Centre clinical Soyaux France Not Yet Recruiting
Hôpital Privé Océane Vannes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06822452 on ClinicalTrials.gov ↗ ← All trials in France