Combined Keyhole and Open Surgery vs Bypass Surgery for Severely Blocked Leg Arteries
For people with: Critical Limb-Threatening Ischaemia
About this trial
This trial is for people with very poor blood flow in their legs because of blockages at more than one level. We are comparing a newer combined approach (part keyhole, part open surgery) with a traditional bypass operation, to see which gives better results and a faster recovery.
What would I need to do?
If you take part, you will be randomly assigned to one of two treatment groups. One group will have a combined procedure using both keyhole and open surgical techniques. The other group will have a traditional bypass operation. You will have follow-up visits at 1, 3, 6 and 12 months to check the blood flow in your leg and monitor your recovery.
After your operation, you will be monitored in hospital. Once home, you will come back at 1 month, 3 months, 6 months, 12 months and 24 months. At each visit, you will have an ultrasound scan of the bypass or stent, and the team will check your wounds and symptoms. If you have a wound on your leg or foot, it will be photographed to track healing.
Could I take part?
You may be eligible if you have severe leg pain at rest, non-healing wounds, or are at risk of losing your leg due to blocked arteries at more than one level. Your vascular surgeon will assess whether either approach is suitable for you.
Age range: 18 years and over
What are the risks and benefits?
Both approaches aim to save your leg and improve blood flow. The combined (hybrid) approach may mean a shorter operation and quicker recovery, but the long-term results are not yet known. The traditional bypass has a longer track record but is a bigger operation with a longer recovery. Both carry risks of bleeding, infection, graft failure and (rarely) heart or lung complications. By taking part, you will be closely monitored and help determine the best approach for future patients in your situation.
Common questions
Interested in taking part?
Contact the research team to find out more about this trial and whether it might be right for you.
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