RecruitingOBSERVATIONAL

Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

This study is about developing and testing new computer-assisted tools for surgeons performing abdominal operations. The goal is to create systems that can show surgeons the exact location of important body parts, like blood vessels, organs, or tumours, on a screen in real-time. This extra information could help surgeons make more precise decisions during surgery. Researchers will use existing patient data to develop these tools and then evaluate how well they work during planned operations. Ultimately, this research aims to improve surgical care by supporting doctors with advanced technology, making operations potentially safer and more effective for patients through better visualisation and guidance.

At a glance

Status

Recruiting

Sponsor

Technische Universität Dresden

Enrolment target

Start

19 May 2021

Estimated completion

31 Dec 2050

Abdominal Surgery

What is this study about?

Imagine surgeons having a kind of 'GPS system' that shows them exactly where everything is inside your body during an operation. That's a bit like what this research is trying to achieve.

This study, called IDEMONSTRATE, is focused on creating and testing advanced computer tools for abdominal surgery. These tools might use technology like augmented reality (where computer images are added to real-life views) or special navigation systems to give surgeons a clearer, real-time picture of important structures like blood vessels, organs, or even tumours. The main idea is to help surgeons perform operations more accurately.

The research has two main parts. First, the team will use information from past surgeries to develop these new assistance tools. They are looking at routine data collected from patients to build a system that can accurately show where anatomical structures are. Second, they will carefully evaluate these tools during planned operations. This means doctors will use the new system during surgery to see how well it works and if it genuinely helps them. The ultimate aim is to make surgery better and safer for patients by giving surgeons the best possible guidance.

Key takeaways

New computer tools are being developed to help surgeons during abdominal operations.
These tools aim to give surgeons a real-time, clearer view of body parts like blood vessels and organs.
The study assesses how well these tools work in a normal surgery setting.
Participation means the new tools are used during your planned surgery, with no change to your care.
The goal is to improve surgical precision and safety for future patients.

Who may be eligible?

To be able to take part in the evaluation part of this study, you would need to be an adult, aged 18 or older.

You would also need to be scheduled for an abdominal operation where the surgeon will be using certain types of equipment. This could include a keyhole surgery camera (laparoscopic camera), an open surgery camera, or a surgical robot (like the DaVinci system). It could also apply if they are using special imaging during your operation, such as an ultrasound or an intraoperative CT scan.

Crucially, you must be able to understand German to give your full informed consent to participate. If you are unable to give consent for any reason, you would not be eligible.

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 scheduled for an abdominal surgery using a camera or special imaging?
Do you understand German?
Are you able to give your informed consent freely?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, it means that during your planned abdominal surgery, the surgeons will use the newly developed computer-assisted system alongside their standard procedures. The new system is designed to provide extra visual guidance and information during the operation. This doesn't involve any changes to your medication or additional procedures that wouldn't normally happen. The researchers will simply be observing and assessing how well their new technology performs in a real operating theatre setting. Your surgery itself would be carried out as planned, with the additional technology being used to assist the surgical team. There are no extra visits or follow-up appointments specifically for this study; it seamlessly integrates into your existing surgical plan. The total duration of your involvement would be limited to the time of your surgery.

Potential risks and benefits

There are potential benefits to this research, as better tools for surgeons could lead to more precise and potentially safer operations for patients in the future. However, for you as an individual participant, the direct benefit during your surgery is mainly that you are contributing to science. The new system is being evaluated, and while it's designed to assist, it's not yet proven to directly improve your outcome beyond standard care. In terms of risks, the researchers are very careful. The system is evaluated exclusively during planned operations, not emergencies, and only specialist surgeons who are fully informed about its use will be involved. The system is designed to provide information and is not making surgical decisions itself. You always have the right to withdraw your consent at any time, even if you initially agreed to participate.

Locations (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is this study trying to do?

It's trying to create new computer tools to help surgeons see inside your body more clearly during abdominal operations, aiming for safer and more precise surgery.

Will this change my surgery?

No, your surgery will proceed as planned. The new tools will simply be used by the surgical team to give them extra information and guidance during the operation.

Is this a new medicine or drug trial?

No, this study is not about medicines. It's about developing and testing new technology and computer systems to assist surgeons.

Who will be using these new tools?

Only experienced specialist surgeons who have been fully informed and trained will use the developed system during planned operations.

What if I don't want to take part?

Taking part is completely voluntary. If you choose not to participate, it will not affect your medical care in any way.

How to find out more

Marius Distler, Prof. Dr.

marius.distler@ukdd.de +49 351045818264 Official trial record

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