Comparing intraoperative indocyanine green fluorescence imaging with standard clinical assessment for flap perfusion in head and neck reconstruction: A randomised controlled Trial (VISION Trial)
This study, called the VISION Trial, is investigating a new method to help surgeons check blood flow during head and neck cancer surgery. When surgeons remove cancer, they often use a piece of tissue (called a 'flap') from another part of the body to rebuild the area. Ensuring good blood supply to this flap is crucial for healing. This study compares using a special dye injection (indocyanine green) that lights up under a specific camera, against the standard ways surgeons currently check. The main goal is to see if this new method can reduce the number of times a flap doesn't heal properly and needs more surgery within one month.
At a glance
What is this study about?
When someone has head and neck cancer removed, surgeons often take tissue from another part of the body, like the arm or leg, to reconstruct the area. This new tissue, called a 'flap,' needs a good blood supply to heal properly and become a successful part of your body. Sometimes, the blood flow to the flap isn't as good as it should be, which can lead to problems and might even require more surgery.
This study, called the VISION Trial, is looking into a way to help surgeons check this blood flow during the operation itself. They will be using a special dye called indocyanine green. This dye is injected into your body and then, when a special camera is used, it lights up, showing the surgeons exactly how well the blood is flowing to the new flap. The study wants to see if using this dye is better than the usual ways surgeons check the blood flow, hoping it can lead to fewer problems with the flap after surgery.
The main thing the doctors are trying to find out is if using this special dye helps reduce the chances of parts of the flap not getting enough blood and needing another operation within a month of your initial surgery. They will also be looking at other things, like whether the whole flap fails, how often a flap needs to be re-explored under anaesthetic, how often a struggling flap can be saved, and any other health problems you might have after the operation.
Key takeaways
- Studies a new way to check blood flow during head and neck reconstruction surgery.
- Compares a special dye injection with standard methods.
- Aims to reduce problems with reconstructed tissue (flaps).
- Focuses on preventing the need for further surgery on the flap.
- Involves adults having head and neck cancer surgery.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit. Both men and women can take part.
More specific details about your health and the type of head and neck cancer you have would be discussed by your doctor to make sure this study is right for you. Generally, you would be someone who is having surgery for head and neck cancer where tissue will be moved from one part of your body to another for reconstruction.
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.
- Am I 18 years old or older?
- Am I having surgery for head and neck cancer?
- Will my surgery involve using a tissue flap for reconstruction?
- Am I generally able to participate in a clinical study?
What does participation involve?
If you decide to take part in this study, the main difference from your standard surgery would be the use of a special dye injection during your operation. This dye, called indocyanine green, will be given directly by the medical team. This will allow the surgeons to get a clearer picture of the blood flow to your reconstructed area (the flap) using a special camera.
After your surgery, the research team will closely monitor your recovery for at least one month. They will be looking to see how well your flap is healing and if there are any complications, especially within the first month. They will also follow up on your overall health for up to three months after the surgery. There will be specific assessments done during this time, but these will largely align with the usual care you would receive after such an operation.
Potential risks and benefits
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Common questions
What is 'flap perfusion'?
Flap perfusion simply means the blood flow to the piece of tissue (the 'flap') that surgeons use to rebuild an area after cancer removal.
What is indocyanine green?
It's a special dye that glows under a specific light, allowing surgeons to see the blood flow to your new tissue flap clearly during surgery.
Will this dye make me glow?
No, the dye only lights up under a special camera used by the surgeons during the operation. It won't make you glow afterwards.
What does 'partial flap loss' mean?
It means part of the reconstructed tissue flap didn't get enough blood flow and started to have problems, potentially needing further surgery.
Is this a new type of treatment for cancer?
No, this study isn't about a new cancer treatment. It's about improving a surgical technique used during reconstruction after cancer has been removed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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