A Prospective Study of Fortiva in Hernia Repair
This study is gathering information about a product called Fortiva Tissue Matrix, which is used during operations to fix hernias. Doctors want to find out how safe and effective this material is for patients. If you're having hernia surgery where Fortiva Tissue Matrix is used, you might be asked to join. Taking part means you'll answer some questions over two years after your surgery to share your experience. This helps medical professionals understand the long-term results and performance of this material in real-world use. It's an important way to make sure new treatments are working well for patients.
At a glance
What is this study about?
This study is about a special material called Fortiva Tissue Matrix, which doctors use when they perform surgery to repair a hernia. A hernia happens when an organ pushes through a weak spot in a muscle or tissue. The Fortiva Tissue Matrix is a medical product designed to help strengthen the area during hernia repair operations.
The main goal of this study is to see how safe and effective the Fortiva Tissue Matrix is for patients. Doctors are keen to understand if it helps people recover well and if there are any problems with it over time. They will follow about 120 patients at different hospitals to get a good overall picture.
By taking part, you would be helping medical science learn more about the best ways to treat hernias. Your experiences and feedback would provide valuable information that can help future patients undergoing similar surgery.
Key takeaways
- This study observes how a material called Fortiva Tissue Matrix works during hernia surgery.
- It aims to check the safety and performance of this material over two years.
- Participation involves answering questionnaires and attending follow-up appointments.
- It's for people 18 or older having specific hernia repair surgery.
- Your feedback helps doctors learn more about hernia treatments.
- You can stop participating at any time without affecting your care.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old when you agree to participate. You must also be scheduled for hernia surgery where your surgeon plans to use the Fortiva Tissue Matrix.
It's important that you don't have any health conditions that would make using the Fortiva Tissue Matrix unsafe for you. You should also be able to understand what the study involves and be willing to answer questionnaires and attend follow-up appointments. This means you need to be able to read and understand the questions and come back to the hospital as planned.
You wouldn't be able to join if you are under 18, or if you have certain very serious health problems classified by anaesthetists (ASA class 4, 5, or 6). Also, if you currently have an infection near the hernia site, or if you're already in another study that might affect this one, you wouldn't 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 having hernia surgery where your surgeon will use Fortiva Tissue Matrix?
- Are you able to understand study information and fill out questionnaires?
- Can you attend follow-up appointments for two years?
- Do you have any severe health conditions like advanced heart or lung failure? (If yes, you may not be able to join)
- Are you currently fighting an active infection near your hernia?
What does participation involve?
If you decide to take part in this study, your involvement would primarily focus on sharing your experience after your hernia operation. You would have your hernia surgery as planned, and the Fortiva Tissue Matrix would be used during that procedure. After your surgery, you will be asked to complete some questionnaires. These questionnaires will ask about your recovery and how you are feeling after the operation.
You will need to attend scheduled follow-up visits with your doctor. These visits are important for the medical team to check on your progress and for you to complete the questionnaires. The study will follow your progress for two years after your operation, so you'll be giving feedback over this time. There isn't any extra medication involved in this study; it's about observing how well the Fortiva Tissue Matrix works in your standard hernia repair.
Potential risks and benefits
Locations (1)
- James Paget University HospitalVerified postcodeGreat Yarmouth, United Kingdom
Common questions
What is a hernia?
A hernia is when an organ, fat, or intestine pushes through a weak spot in the muscle or tissue that's supposed to hold it in place. It often shows as a bulge.
What is Fortiva Tissue Matrix?
It's a special material used by surgeons during hernia operations to help strengthen the weakened area and support the repair.
Will I get special treatment if I join?
No, you'll receive the same high standard of hernia care as any other patient. The study is about observing how well the Fortiva Tissue Matrix works during regular surgery.
How long will I be involved?
If you join, doctors will follow your health and invite you to complete questionnaires for two years after your hernia surgery.
What if I change my mind about participating?
You are completely free to withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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