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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorElsan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • radical prostatectomy

    Procedure/Surgery

    Robot-assisted

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: Outpatient procedureExperimental treatment 1 intervention
Group B: Inpatient procedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early complication of robot-assisted prostatectomy

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

Time frame
From the day of surgery to 8 days post-operative

Secondary outcomes

1

Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)

Patients treated on an outpatient basis for whom full hospitalisation is indicated on the day of surgery, as decided by the medical team.

Time frame
Day of surgery
2

Rate of cancellation of outpatient treatment by the patient or his private environment

Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason

Time frame
From enrollment to the day of surgery
3

Rate of patients readmitted to hospital, either as emergencies or in the department

Patients readmitted to hospital (yes/no), emergency or inpatient department

Time frame
From hospital discharge to 8 days post-operative.
4

Association of each early complication with treatment (outpatient or inpatient)

Early complication of robot-assisted prostatectomy

Time frame
From hospitalisation discharge to 8 days post-operative

Other outcomes

Sponsors and contacts

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