European TIF2.0 Registry
This Europe-wide study is looking at a treatment called Transoral Incisionless Fundoplication (TIF) for people who have reflux. Reflux is when stomach acid comes back up, causing symptoms like heartburn, indigestion, and sometimes a sore throat. The TIF procedure is a type of 'keyhole' surgery done through the mouth, which aims to strengthen the barrier between your food pipe and stomach. Sometimes, this is done at the same time as fixing a small hernia near the stomach. Doctors want to see how well this treatment works and how safe it is for patients with reflux throughout Europe. They are gathering information from many hospitals to understand its effects better.
At a glance
What is this study about?
This study is called the European TIF2.0 Registry, and it's looking at a specific treatment for reflux. Reflux happens when stomach acid and sometimes food flow back up into your food pipe (oesophagus), causing symptoms like heartburn, a sour taste in your mouth, chest pain, and sometimes even a sore throat or hoarseness if it reaches your voice box. This study is tracking how well a procedure called Transoral Incisionless Fundoplication, or TIF for short, works in real patients.
The TIF procedure is a special type of surgery that's often called 'keyhole' surgery because it's less invasive. Instead of making cuts in your skin, surgeons perform the procedure through your mouth using a special device. The goal is to rebuild the natural anti-reflux barrier between your food pipe and your stomach, which helps stop acid from coming back up. For some people, this is also combined with fixing a small problem called a hiatal hernia, where part of the stomach pushes up into the chest.
By collecting information from many hospitals across Europe, doctors hope to get a clear picture of how safe and effective the TIF procedure is for a wide range of patients. This will help them understand who might benefit most from this treatment and make sure it's a good option for people suffering from reflux.
Key takeaways
- This study is collecting information on a keyhole surgery for reflux called TIF.
- It aims to see how safe and effective the TIF procedure is.
- The surgery is done through your mouth, with no cuts on the skin.
- It sometimes includes repairing a small hernia near the stomach.
- The study is for adults over 18 who are already having the TIF procedure.
- Your decision to join or leave the study will not affect your medical care.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years of age or older. You must be having the TIF procedure, or a combined TIF with hernia repair, at one of the hospitals taking part in this study.
It's important that you can understand the information about the study and are happy to sign a consent form, which means you agree to take part. This ensures you know what's involved and agree to your information being used for the study.
There are no specific reasons that would automatically stop you from joining this study, as long as you meet the basic requirements mentioned above and are having the TIF procedure.
- Are you 18 years old or older?
- Are you planning to have the TIF procedure or TIF with hernia repair for your reflux?
- Is your hospital taking part in this study?
- Can you understand the study information and agree to take part?
- Are you happy for your medical information from your TIF procedure to be collected for research?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will essentially be allowing information about your TIF procedure and how you recover afterwards to be collected and studied. You won't be given any new or experimental medications as part of the study; it's focused on understanding a treatment that's already in use.
Taking part means that your healthcare team will record details about your health before the procedure, during the procedure itself, and how you feel and recover over time. This might involve answering questionnaires about your symptoms and quality of life at different points after your surgery. The exact number of follow-up visits or assessments will be explained to you by the study team at your hospital, but it generally involves regular check-ins to see how you're doing. The total duration of your involvement will depend on how long the study continues to track patient outcomes, but your personal follow-up schedule will be clear.
Potential risks and benefits
Locations (7)
- Department of General Surgery, Medical University of ViennaVienna, Austria
- Gemelli IsolaRome, Italy
- University Hospital for Digestive SurgeryBelgrade, Serbia
- IntestoBern, Switzerland
- Memorial bahçelievler hospitalIstanbul, Turkey (Türkiye)
- Cleveland ClinicAbu Dhabi, United Arab Emirates
- Cleveland Clinic LondonLondon, United Kingdom
Common questions
What is reflux?
Reflux is when stomach acid or food flows back up into your food pipe, causing symptoms like heartburn, a sour taste, or a sore throat.
What is the TIF procedure?
TIF is a 'keyhole' surgery for reflux, done through your mouth. It aims to strengthen the barrier between your food pipe and stomach.
Will I have a scar if I have TIF surgery?
No, because the TIF procedure is done through your mouth, it doesn't involve any cuts on your skin, so there won't be any scars.
Am I getting a new or experimental treatment?
No, this study is looking at a treatment (TIF) that is already in use. We are gathering more information about how it works for many patients.
Who is running this study?
This is a European study involving many hospitals. The results will help doctors across Europe understand the TIF procedure better.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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