Comparing outpatient and inpatient robotic prostate surgery outcomes
Official title: Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
Run by Elsan · NCT06822452 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 510 (estimated) |
| Sponsor | Elsan Academic / other |
| Locations | 12 sites (Avignon and 11 other locations) |
| Status | Recruiting |
| Started | December 30, 2024 |
| Main results expected | January 7, 2027 |
| Study ends | April 30, 2030 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT06822452 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males aged 18 and over diagnosed with prostate cancer who are eligible for outpatient radical prostatectomy.
✕Probably not a fit
Patients who require inpatient management due to severe comorbidities or complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results for outpatient surgical approaches, suggesting that this method may be viable and effective.
Who can join: the full rules
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 it's running
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Clinique St Vincent
Besançon, France Recruiting -
Clinique St Augustin
Bordeaux, France Recruiting -
Polyclinique Médipôle St-Roch
Cabestany, France Recruiting -
Pole Sante Sud-CMCM
Le Mans, France Recruiting -
Polyclinique Les Fleurs
Ollioules, France Recruiting -
Clinique Belledonne
Saint-Martin-d'Hères, France Recruiting
Show 6 more locations
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Hôpital Privé Océane
Vannes, France Recruiting -
Clinique Rhône Durance
Avignon, France Not yet recruiting -
Polyclinique du Parc
Caen, France Not yet recruiting -
Hôpital Privé Nancy Lorraine
Nancy, France Not yet recruiting -
Polyclinique Santé Atlantique
Saint-Herblain, France Not yet recruiting -
Centre clinical
Soyaux, France Not yet recruiting
Study contacts
- Study coordinator: Charlène PY, Eng
- Email: charlene.py@elsan.care
- Phone: +33556003048
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PSMA-targeted fluorescent dye OTL78 to guide prostate cancer surgery
This study tests whether the PSMA-targeted fluorescent dye OTL78, used with near-infrared imaging, can help doctors better find and remove prostate cancer tissue during surgery in men with confirmed prostate cancer.
-
Ambient AI scribe (Voa Health) to help write outpatient clinic notes and reduce documentation burden
This project tests whether an ambient AI scribe (Voa Health) that drafts clinical notes during adult outpatient visits can reduce doctors' documentation workload and improve physician well‑being and patient experience.
-
Robotic Prostatectomy Pain Reduction with Two Insufflation Devices
This trial tests whether two different pneumoperitoneum devices used during robotic prostatectomy affect pain after surgery in men with prostate cancer.
-
High-resolution imaging to check if tumors are completely removed during surgery
This study is testing if high-resolution imaging during surgery can help make sure all tumors are removed in patients with different types of cancer, like breast, prostate, and thyroid, to improve their treatment outcomes.
-
Extended versus no pelvic lymph node removal during radical prostatectomy
This trial tests whether removing more pelvic lymph nodes during prostate removal surgery helps men with high‑risk prostate cancer who have no metastases on PSMA‑PET.
-
Evaluating the effects of dexmedetomidine in outpatient surgery anesthesia
This study is testing if using dexmedetomidine instead of opioids during outpatient surgeries can help patients feel better and wake up more smoothly after anesthesia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.