RecruitingNAINTERVENTIONAL

Rein 3D PRINT PERSONALIZE

This study, called "Rein 3D PRINT PERSONALIZE," wants to see if using a special 3D printed model of a patient's kidney, showing their specific tumour, helps them and their family feel more informed and less anxious before kidney surgery. We're comparing this personalised model to a more general 3D kidney model. The main aim is to understand how these models affect a patient's experience both before and after an operation to remove part of their kidney while keeping the rest healthy. We will be talking to patients and their carers to get their views. The study hopes to find new ways to make patients feel more at ease and better understand their treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

28 May 2024

Estimated completion

15 Jun 2027

Tumoral Kidney

What is this study about?

Imagine you need an operation on your kidney because of a tumour. This study is exploring a new way to help you understand your surgery better. Doctors are looking at whether showing you a custom-made 3D model of your own kidney, complete with your specific tumour, makes a difference compared to showing you a general 3D kidney model.

The main idea is that seeing a model that's exactly like yours might help you and your family feel more prepared and less worried before the operation. We want to see if it helps you understand what's happening more clearly. For example, it might make it easier to ask questions and have better conversations with your doctors and nurses. This study is focusing on an operation called partial nephrectomy, where only the part of the kidney with the tumour is removed.

We know that feeling anxious before surgery is common, and understanding exactly what's going to happen can make a big difference to how you feel, both before and after the operation. This study wants to find out if using these 3D models can improve your experience and make your care journey smoother.

Key takeaways

Compares personalised vs. general 3D kidney models for patient education.
Aims to improve patient understanding and reduce anxiety before surgery.
Focuses on patients having partial kidney removal for a tumour.
Uses interviews and questionnaires to gather patient experiences.
You'll get extra time to discuss your surgery with doctors.
Participation will not change the medical treatment you receive.

Who may be eligible?

To take part in this study, you must be 18 years or older and be scheduled for a specific type of kidney surgery called a laparoscopic robotic-assisted partial nephrectomy. This means you're having an operation to remove a kidney tumour, and it's your first time having kidney cancer surgery on that kidney. You'll also need to be able to understand and speak French (as the study is in France) and be part of their social security system.

You would not be able to join if your cancer has spread to other parts of your body, if you've had kidney cancer before, if you only have one kidney, or if the scans of your kidney aren't clear enough to create a detailed 3D model. Also, if you have difficulty understanding or speaking French, or are under legal protection, you wouldn't be able to participate.

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 or older?
Are you having your first operation for a kidney tumour?
Is your surgery a specific type called 'laparoscopic robotic-assisted partial nephrectomy'?
Can you understand and speak French easily?
Do you not have cancer that has spread to other parts of your body?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. One group will be shown a personalised 3D model of your kidney and tumour before your surgery. The other group will be shown a more general 3D model of a kidney. You'll spend time with doctors learning about your condition and surgery using these models.

You'll be asked to fill out questionnaires about how well you understand health information, how much you know about your kidney and tumour, and how satisfied you are with using the 3D model. You'll also have short, informal chats (semi-structured interviews) with researchers at three different points: before your surgery, shortly after, and then again a bit later. The total duration of your participation will depend on when these interviews take place, but the main intervention (seeing the model) happens before surgery.

Potential risks and benefits

Participating in this study might help you understand your upcoming kidney surgery more clearly, potentially reducing any anxiety you might have. You'll have extra time with doctors to discuss your condition using a visual aid. There are no direct medical risks from participating, as the study focuses on how information is given to you, not on the surgery itself. However, you might spend a little extra time in consultation for the interviews and questionnaires. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is a 3D kidney model?

It's a physical, 3-dimensional copy of a kidney, either a general one or one made exactly like yours from your scans, showing your tumour.

Why is this study important?

It helps us learn if special models can make patients feel more informed and less anxious about their kidney surgery.

Will I get to keep the 3D model?

The study description doesn't say you'll keep the model, but it will be used to help explain your surgery before the operation.

Will this change my surgery?

No, your surgery will be the same regardless of which group you are in. The study is about how information is given to you.

How long does participation last?

You'll have a few discussions and fill out some questionnaires before and after your surgery. The full study duration for you would be determined by the timing of these follow-up chats.

How to find out more

Gaëlle MARGUE, Dr

gaelle.margue@chu-bordeaux.fr 00335 57 82 17 62 Official trial record

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