Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
This study aims to discover if a new, safe imaging method can accurately diagnose testicular torsion in boys who come to the hospital with sudden testicle pain. Testicular torsion is a serious condition where the testicle twists, cutting off blood supply, and needs an urgent operation. Currently, many boys have surgery just to check for torsion, even if they don't have it. This new test uses a special dye called indocyanine green and a special camera to see blood flow. If successful, it could help doctors avoid unnecessary operations for some children and ensure that all boys who do have torsion get treated quickly, potentially saving their testicle.
At a glance
What is this study about?
When children and young people experience sudden pain in their testicles, it can sometimes be due to a serious condition called testicular torsion. This is where the testicle twists, cutting off its blood supply, and it needs an urgent operation to fix it. If not fixed quickly, the child could lose their testicle. At the moment, it's very hard to properly diagnose torsion without surgery, which means many boys end up having an operation just to check, even if they don't have the problem. This can be stressful and isn't ideal for children who don't need surgery.
This study is looking into a new, quick, and low-risk test that might help doctors make a clearer diagnosis. The new test involves injecting a special dye, called indocyanine green (ICG), and then using a special camera to take pictures of the testicle. This camera uses a special light that helps doctors see how blood is flowing, which can indicate if there's a problem like torsion. This test is already used in other hospitals and is considered safe.
The main goal is to see if this new imaging method can accurately tell the difference between boys who have testicular torsion and those who don't. If it works well, it means fewer children might need unnecessary operations, while still making sure that everyone who genuinely has torsion gets the urgent treatment they need to save their testicle.
Key takeaways
- The study aims to improve diagnosis of twisted testicles in boys.
- A new imaging method uses a safe dye and special camera.
- This could help avoid unnecessary operations for some children.
- It also ensures cases of twisted testicles are treated quickly.
- Participation is only for boys having surgery for testicle pain.
Who may be eligible?
This study is open to boys and young men usually between birth and 19 years old. They must be coming to Sheffield Children's NHS Foundation Trust because they have sudden testicle pain and the doctors think they might need an operation to check for a twisted testicle.
You won't be able to take part in the study if you have ever had an allergic reaction to a special dye used in medical tests (called contrast medium) or to iodine. Also, if you, or your parent or guardian (if you're under 13), decide you don't want to be involved, then you won't take part. It's always your choice.
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 a male between birth and 19 years old?
- Are you coming to Sheffield Children's NHS Foundation Trust for sudden testicle pain?
- Are doctors considering surgery to check for a twisted testicle?
- Do you have any known allergies to special dyes or iodine?
- Are you happy to consider taking part?
What does participation involve?
If you are eligible and agree to take part, the study special dye (indocyanine green) will be injected into your arm or hand once you are already asleep for your operation. Then, before your surgeon starts the main part of the operation, a special camera will take a quick picture of your testicle. If the doctors find a twisted testicle during the operation, they will fix it and might take another picture with the camera afterwards. This whole process only adds a few minutes to your time in the operating room. Your doctors will also record information about your pain and what they find during your surgery. There are no extra hospital visits or follow-up appointments specifically for this study.
Potential risks and benefits
Locations (1)
- Sheffield Children's HospitalVerified postcodeSheffield, United Kingdom· Recruiting
Common questions
What is testicular torsion?
Testicular torsion is when a testicle twists inside the scrotum, cutting off its blood supply. It causes sudden, severe pain and requires urgent treatment.
Why is this study needed?
Currently, it's hard to tell if a boy has testicular torsion without surgery. This study hopes to find a better, quicker way to diagnose it and avoid unnecessary operations.
What is indocyanine green (ICG)?
ICG is a special, safe dye that doctors inject into the bloodstream. It helps a special camera see how blood is flowing to the testicle.
Will taking part change my operation or recovery?
The study procedure adds only a few minutes to your time in the operating room and is done while you are already asleep for your surgery. It should not affect your recovery.
Is the new camera dangerous?
No, the special camera uses light that is not harmful. It's a technology already used safely in other hospitals.
How to find out more
Caroline MacDonald, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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