RecruitingOBSERVATIONAL

Electrosurgical Intervention Analysis: Comparing Procedure Patterns

This study is gathering information about how special electrical equipment, called an electrosurgical unit, is used during certain operations. We believe that each different type of surgery creates a unique electrical pattern, like a digital "fingerprint." By collecting these electrical patterns, we hope to build a database that could help doctors identify specific steps in procedures and improve surgical training. Importantly, this study only collects electrical data and does not involve changing how your surgery is performed or looking into the safety of the equipment itself. We are not collecting any personal patient information.

At a glance

Status

Recruiting

Sponsor

University Hospital Tuebingen

Enrolment target

160

Start

21 Feb 2024

Estimated completion

01 Jun 2026

Surgical Procedure, Unspecified

What is this study about?

Imagine your body like a complex electrical circuit during surgery. When doctors use special tools that involve electricity, like those that cut or seal tissues, these tools generate electrical signals. This study is focused on collecting and understanding these electrical signals.

We believe that each different type of surgery, whether it's a hysterectomy or a certain type of breast surgery, has its own unique electrical pattern or "fingerprint." Think of it like a song – every song has a distinct sound pattern. We're trying to find these unique electrical patterns for different surgeries. We do this by connecting a special device to the surgical equipment during your operation. This device records the electrical information and sends it to a secure cloud storage system. No personal patient information is collected, only the electrical data from the surgical tools.

Why is this important? By understanding these electrical fingerprints, we hope to create new ways to train surgeons. For example, if we know the typical electrical pattern for a specific step in a surgery, we could use this information to help trainee surgeons learn and refine their skills. It could also help experienced surgeons reflect on their procedures and continuously improve. This study is the first step in building a rich database of these electrical fingerprints, which we hope will lead to better and safer surgical practices in the future.

Key takeaways

This study collects electrical tool data during surgery, not patient information.
It aims to find unique 'electrical fingerprints' for different operations.
The goal is to improve surgeon training and surgical techniques for future patients.
Your surgery will not be changed or affected if you participate.
Participation involves no extra visits, tests, or follow-up.
There are no direct risks or benefits to you.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and agree to join by signing a consent form. You might be eligible if you are having one of these specific operations: a subtotal hysterectomy (removal of part of the womb), a total hysterectomy (removal of the whole womb), or certain breast-conserving surgeries, which include breast shaping with a lift around the nipple, or removal of a specific part of the breast.

However, you won't be able to join the study if you're under 18 or if you're unable to understand what the study is about or follow instructions. You also can't take part if you're having your surgery under only local anaesthetic (meaning only a small part of your body is numbed and you're awake), or if your surgery involves a robot (robot-assisted surgery). This study is only open to women.

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 a woman?
Are you able to understand what the study is about?
Are you having a subtotal hysterectomy, total hysterectomy, or specific breast-conserving surgery?
Will you be having general anaesthesia (where you are fully asleep for the operation)?
Is your surgery NOT robot-assisted?

Answer every question to see your result.

What does participation involve?

If you decide to take part, there will be no changes to your actual surgery or how your care is given. The study team will simply connect a harmless device to the electrosurgical equipment being used during your operation. This device will silently record electrical data from the surgical tools. You won't have any extra appointments, tests, or follow-up visits related to this study. The recording will only happen during your surgery, and your participation will end once your surgery is complete. No medication is involved in this study. The total duration of your involvement is only during your surgery.

Potential risks and benefits

There are no direct benefits to you personally for taking part in this study, as it's purely about collecting data from equipment. However, the information gathered could help improve surgical training and techniques for patients in the future. As this study only involves connecting a device to existing surgical equipment and does not change your procedure, there are no known risks to your health or safety. Your personal information will not be collected or linked to the electrical data. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care in any way.

Locations (1)

University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

Will my surgery be different if I join this study?

No, your surgery will be exactly the same whether you join the study or not. We are only observing the electrical patterns from the equipment.

Will my personal details be collected?

Absolutely not. The study only collects electrical data from the surgical equipment; no patient information is recorded or stored.

Is this study looking at new equipment?

No, we are using standard electrical surgical equipment that is already approved and used regularly. We are just collecting data from it.

What happens to the electrical information collected?

The information is stored securely and analysed to find unique electrical patterns for different surgeries. This is then used for research into improving surgical training.

Can I change my mind after agreeing to take part?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Bernhard Krämer, Prof. Dr.

bernhard.kraemer@med.uni-tuebingen.de +497071-2982211 Official trial record

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