Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
This study looks at prostate cancer surgery where a robot helps the surgeon. It's designed to compare how people recover when they go home on the same day (outpatient) versus staying overnight in the hospital (inpatient). The main aim is to see if recovering at home causes similar early problems as staying in the hospital for a short period. Researchers want to find out if leaving the hospital sooner is just as safe. Participants will have regular check-ups for up to five years, answer questions about their health, and keep a diary of their care. This will help understand the short-term recovery experience and how well people feel after their surgery.
At a glance
What is this study about?
If you're facing prostate cancer surgery, you might be wondering about your recovery. This study is looking into a modern way of doing prostate surgery called "robot-assisted radical prostatectomy." In this type of operation, special robotic tools help the surgeon remove the prostate gland.
Usually, after surgery, patients stay in the hospital for a little while to recover. But doctors are now exploring if it's safe for some patients to go home on the same day after this specific robot-assisted surgery. This study wants to find out if going home on the same day leads to similar early recovery experiences and complications as staying in the hospital overnight. They want to compare both options to see if recovering at home can be just as good and safe for certain people.
By comparing these two approaches, the study hopes to gather important information that could help future patients. It will help doctors understand better who might be suitable for recovering at home and ensure that this option is safe and doesn't lead to more problems in the early recovery period.
Key takeaways
- This study compares same-day recovery versus overnight hospital stay after robot-assisted prostate surgery.
- It aims to confirm that going home sooner doesn't increase early complications.
- Participants will have regular check-ups for five years and complete surveys on their recovery.
- You need to be able to follow medical advice and have support at home for same-day discharge.
- The study helps doctors understand the safest and best recovery options for prostate cancer patients.
Who may be eligible?
To join this study, you must be a man aged 18 or older who has prostate cancer. Your doctors must have suggested a robot-assisted operation to remove your prostate as the best treatment for you. You also need to be a good fit for going home on the same day after surgery. This means you should be able to follow medical advice, have a way to get home and back to the hospital if needed (like a family member driving you), and have access to a phone.
You'll need someone responsible to be with you when you go home and for the first 24 hours to help look after you and understand the instructions. Also, you must be prepared to stay in the hospital overnight if the doctors decide it's better for your care. You also need to be part of a social security scheme, like paying National Insurance contributions or benefiting from one.
You won't be able to join the study if you've already had other treatments for prostate cancer like radiotherapy, brachytherapy, or focal therapy. If you're involved in another medical study or can't follow the study's rules for any reason, you won't be able to take part. Also, if you're under legal guardianship or are in custody, you can't join the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man aged 18 or older with prostate cancer?
- Has your doctor recommended robot-assisted surgery to remove your prostate?
- Do you have a responsible person who can take you home and stay with you for 24 hours after surgery?
- Are you able to follow medical instructions and communicate by phone?
- Have you not had previous treatments like radiotherapy for your prostate cancer?
What does participation involve?
If you join this study, you'll still have your robot-assisted prostate surgery as planned. After your operation, whether you go home the same day or stay overnight, you'll have several follow-up visits. You'll need to visit the clinic once about 45 days after your surgery, then again at 6 months, and finally once a year for up to five years. These visits are for check-ups and any necessary tests.
For the first six months, you'll also be asked to answer some survey questions. These questions will cover topics like your bladder and sexual functions, how you're coping with stress and anxiety, how satisfied you are with your recovery, and your overall quality of life. You'll also be asked to keep a diary. In this diary, you'll record any treatments or procedures related to your care during the study. This will help the researchers understand your experience and recovery over time.
Potential risks and benefits
Locations (12)
- Clinique Rhône DuranceVerified postcodeAvignon, France· Not yet recruiting
- Clinique St VincentVerified postcodeBesançon, France· Recruiting
- Clinique St AugustinVerified postcodeBordeaux, France· Recruiting
- Polyclinique Médipôle St-RochVerified postcodeCabestany, France· Recruiting
- Polyclinique du ParcVerified postcodeCaen, France· Not yet recruiting
- Pole Sante Sud-CMCMVerified postcodeLe Mans, France· Recruiting
- Hôpital Privé Nancy LorraineVerified postcodeNancy, France· Not yet recruiting
- Polyclinique Les FleursVerified postcodeOllioules, France· Recruiting
- Polyclinique Santé AtlantiqueVerified postcodeSaint-Herblain, France· Not yet recruiting
- Clinique BelledonneVerified postcodeSaint-Martin-d'Hères, France· Recruiting
- Centre clinicalVerified postcodeSoyaux, France· Not yet recruiting
- Hôpital Privé OcéaneVerified postcodeVannes, France· Recruiting
Common questions
What is robot-assisted radical prostatectomy?
It's a type of surgery where a surgeon uses special robotic tools to help remove the prostate gland to treat prostate cancer.
What is the main question this study is trying to answer?
The study wants to see if going home the same day after robot-assisted prostate surgery is as safe as staying overnight in the hospital, in terms of early recovery problems.
How long will I be involved in the study?
Your involvement will last for up to five years, with planned check-ups at specific times after your surgery.
Will I have to pay to be in the study?
No, you don't have to pay to be part of the study. Your participation is about contributing to medical research.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't affect the medical care you receive.
How to find out more
Charlène PY, Eng
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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