Comparing outpatient and inpatient robotic prostate surgery outcomes
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
This study is testing if having robotic prostate surgery as an outpatient is just as safe as having it in the hospital, while also checking how it affects recovery and quality of life for men after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Elsan Academic / other |
| Locations | 12 sites (Avignon and 11 other locations) |
| Trial ID | NCT06822452 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether outpatient robotic-assisted radical prostatectomy is as safe as inpatient procedures regarding early post-operative complications. Participants will undergo the surgery and will be monitored through follow-up visits at 45 days, 6 months, and annually for up to 5 years. They will also complete surveys about their urinary and erectile functions, stress, anxiety, satisfaction, and quality of life for the first 6 months post-surgery. Additionally, participants will maintain a diary to document their care-related procedures and treatments.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and over diagnosed with prostate cancer who are eligible for outpatient radical prostatectomy.
Not a fit: Patients who require inpatient management due to severe comorbidities or complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more convenient outpatient option for patients undergoing prostate cancer surgery.
How similar studies have performed: Other studies have shown promising results for outpatient surgical approaches, suggesting that this method may be viable and effective.
Eligibility criteria
Show full inclusion / exclusion 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 : 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.
Where this trial is running
Avignon and 11 other locations
- 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)
Study contacts
- Study coordinator: Charlène PY, Eng
- Email: charlene.py@elsan.care
- Phone: +33556003048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.