RecruitingOBSERVATIONAL

Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.

This study aims to understand how using robotic technology for bladder removal surgery (called a radical cystectomy) affects patients. Specifically, researchers want to see if this type of surgery changes how much blood a patient loses, how much pain they feel afterwards, and if they need blood transfusions. Some patients might also have their bladder rebuilt during the same operation. This is an observational study, meaning researchers will carefully watch and record information from patients who are already having this surgery. They are not giving new treatments, but rather studying the effects of the robotic surgery that's already planned. The goal is to learn more about the recovery process for patients undergoing this major operation.

At a glance

Status

Recruiting

Sponsor

Goethe University

Enrolment target

Start

01 Aug 2025

Estimated completion

31 Dec 2027

Transfusions Cystectomy Blood Loss Requiring Transfusion Anaemia Anaemia Postoperative Pain, Postoperative

What is this study about?

This study is about a type of surgery called a radical cystectomy. This is a major operation where the bladder is removed, often because of cancer. Sometimes, a new way to store urine is created during the same operation. The researchers want to understand how a modern surgical approach, using robots to help surgeons, affects patients.

They will be looking at a few key things: how much blood a patient loses during and after the operation, how much pain they experience, and if they need a blood transfusion. A blood transfusion is when you're given extra blood because your body has lost too much or isn't making enough. This study isn't testing a new medicine or treatment. Instead, it's observing patients who are already having this robotic surgery as part of their standard care. By gathering information from these patients, doctors hope to learn more about the benefits and challenges of robot-assisted bladder removal.

The information gathered from this study could help doctors better understand the recovery process and improve care for future patients undergoing bladder removal surgery. It’s important to find ways to reduce blood loss and pain, and to avoid transfusions if possible, as these can affect a patient's recovery.

Key takeaways

This study looks at robot-assisted bladder removal surgery.
It aims to understand blood loss, pain, and need for transfusions.
It's an observational study, not testing new treatments.
Participants are already scheduled for this type of surgery.
Information gathered could help future patients.

Who may be eligible?

This study is looking for adults aged 18 or older who are already scheduled to have their bladder completely removed. This surgery is known as a radical cystectomy.

However, there are a few reasons why someone might not be able to join. If you have a very severe overall health condition (classified as ASA V, which means your life is at risk without the operation), you wouldn't be able to take part. Also, if you already have a known problem with your blood clotting, you would not be eligible for this 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 18 years old or older?
Are you planning to have your bladder completely removed (radical cystectomy)?
Do you have a very severe health problem that makes large operations very risky (ASA V)? (If yes, you likely can't join)
Do you have a known problem with your blood clotting or bleeding?
Do you have a different planned surgery than a radical cystectomy?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new treatments or medicines. You will still have your planned robot-assisted bladder removal surgery as normal. The study involves collecting information about your surgery and recovery, such as how much blood you lose, your pain levels, and whether you need blood transfusions. This information will be gathered by the hospital staff as part of your usual care, and then used for the study. There are no extra hospital visits or assessments beyond what you would normally have for your surgery and recovery. The study will mainly involve observing your progress and collecting data that is already being recorded.

Potential risks and benefits

Taking part in this study doesn't involve any extra risks beyond those associated with your planned bladder removal surgery itself, as no new treatments are being given. The main benefit is that your information will help doctors learn more about robotic surgery for bladder removal, which could improve care for others in the future. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Uniklinikum
Verified postcode
Frankfurt am Main, Germany· Recruiting

Common questions

What is a radical cystectomy?

A radical cystectomy is a major operation to remove the bladder, often done because of bladder cancer.

What does 'robot-assisted' surgery mean?

It means the surgeon uses a special robotic system to help with the operation. The surgeon controls the robot's arms, which have tiny surgical tools, from a console.

Will I get a new treatment if I join this study?

No, this study only observes people who are already having standard robot-assisted bladder removal surgery. You won't receive any new treatments or medicines.

How does this study affect my usual hospital care?

It shouldn't affect your usual care. The doctors will simply collect information about your surgery and recovery that they would normally record anyway.

Can I decide not to be in the study once I've joined?

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

Armin Flinspach N PD. Dr. med. habil., M.D.

armin.flinspach@unimedizin-ffm.de +49 69 6301 84136 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.