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

Not Applicable

Recruiting

• Conditions: Ambulatory Care; Prostate Cancer Surgery; Outpatient Surgery

• Registration Number: NCT06822452
• Lead Sponsor: Elsan

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2027-01-07
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 510

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Rate of cancellation of outpatient treatment by the patient or his private environment	From enrollment to the day of surgery	Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason
Rate of patients having had at least one complication secondary to surgery	From 8 days to 45 days post-operative	Patients who had at least one complication secondary to surgery.; The expected complications secondary to surgery are: * Admission to emergency care; * Re-hospitalization; * Occlusions; * Healing problems; * Perineal hematoma; * Urinary infections; * Lymphoceles; * Thromboembolic accidents; * Nosocomial infections
Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)	Day of surgery	Patients treated on an outpatient basis for whom full hospitalisation is indicated on the day of surgery, as decided by the medical team.
Rate of patients readmitted to hospital, either as emergencies or in the department	From hospital discharge to 8 days post-operative.	Patients readmitted to hospital (yes/no), emergency or inpatient department
Rate of patients with at least one complication secondary to surgery	From 45 days to 6 months post-operative	Patients who had at least one complication secondary to surgery.
Association of each early complication with treatment (outpatient or inpatient)	From hospitalisation discharge to 8 days post-operative	Early complication of robot-assisted prostatectomy
Patient satisfaction level	2 days and 45 days post-operative	Patient satisfaction is assessed using the overall satisfaction question in the e-SATIS questionnaire ("Overall, how would you rate the quality of your treatment/care in the department by the doctors/surgeons/nurses? Bad/Weak/Average/Good/Excellent) The patient's opinion (yes/no) is evaluated on whether, if the procedure were repeated, the patient would accept it (yes/no) and whether it reassured him/her to go home in the evening /stay in hospital at night after the procedure.
Patient's pre-operative stress/anxiety levels	3 days before surgery, day of surgery and 2 days post-operative	The participant's stress/anxiety level is assessed at 3 days before surgery using the APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire validated in French (Moerman and al, 1996; Maurice-Szamburski and al, 2013), then with a Numerical Scale of stress/anxiety during preparation for the operating theatre in the care unit and at 2 days post-operative.
Blood loss	Day of surgery	The level of blood loss is assessed by the quantity of blood recovered in the aspiration jar and the quantity from the drains minus the quantity perfused intraoperatively in ml.
Recovery of erectile function	Baseline and 6 months post-operative	Erectile recovery is assessed using the IIEF-5 (International Index of Erectile Function) questionnaire (Rosen R and al, 1997; Dargis and al, 2013) ; erectile dysfunction is defined by an IIEF-5 score \<10.
Oncological recurrence and retreatment	From 45 days to 5 years after surgery	Recurrence is defined by a PSA (Prostate Specific Antigen) level \>0.1ng/ml, the patient's re-treatment (yes/no), the type of re-treatment (hormone therapy / chemotherapy / radiotherapy).
Duration of surgery	Day of surgery	Duration of surgery 'skin-to-skin' (incision until final stitch complete)
Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery	Baseline and 45 days post-operative	Urinary continence is assessed by the response to question 5 of the EPIC-50 (Expanded Prostate Cancer Index Composite) when 0 to 1 pads are used during the day by the patient. Recovery of urinary function was assessed by the difference between the incontinence subscore of the EPIC-50 questionnaire at D45 and the value of the pre-operative score.; The incontinence subscore include questions 1, 3, 4, 5 and 6a of the urinary function EPIC-50 questionnaire. The EPIC-50 is a validated questionnaire (Wei and al, 2000) and translated into French (Anota and al, 2016).
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.	Baseline and 45 days, 6 months after surgery	The evolution of continence and urinary function is established on the basis of the parameters defined previously (see Secondary Outcome Measure 12.)
Economic and social cost of patient care	From hospital discharge to 6 months post-operative	The cost-utility ratio calculated on the basis of : - The costs of the homogeneous group of patients (GHM) for hospitalisation and the costs of the national care reference system (ENCC) for post-operative management, based on the patient's diary completed up to 6 months after the operation.; The following direct medical costs will be estimated from a societal perspective with a time horizon of 6 months: * Medical transport, medical and non-medical consultations in town, complementary examinations and drugs: collected in the CRF of the study from the patient logbook and valued using current tariffs.; * The QALY, a unit for measuring life expectancy weighted by health-related quality of life, calculated on the basis of the utility derived from the EQ-5D-5L quality of life questionnaire completed by the patient at D0, D45 and 6 months after surgery.

Trial Locations

Locations (12)

Clinique Rhône Durance; 🇫🇷 Avignon, France

Clinique St Vincent; 🇫🇷 Besançon, France

Clinique St Augustin; 🇫🇷 Bordeaux, France

Polyclinique Médipôle St-Roch; 🇫🇷 Cabestany, France

Polyclinique du Parc; 🇫🇷 Caen, France

Pole Sante Sud-CMCM; 🇫🇷 Le Mans, France

Hôpital Privé Nancy Lorraine; 🇫🇷 Nancy, France

Polyclinique Les Fleurs; 🇫🇷 Ollioules, France

Polyclinique Santé Atlantique; 🇫🇷 Saint-Herblain, France

Clinique Belledonne; 🇫🇷 Saint-Martin d'Hères, France

Hôpital Privé Océane; 🇫🇷 Vannes, France

Centre clinical; 🇫🇷 Soyaux, France