Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
This research is investigating a new way to reduce complications during bowel cancer surgery. Surgeons often remove part of the bowel and then join the remaining ends. Sometimes, these joins don't heal well, leading to a serious problem called an 'anastomotic leak'. This study uses a special dye, indocyanine green, which glows under a special light during surgery. This helps surgeons see the blood flow to the bowel ends more clearly, hoping to ensure the join has a good blood supply. By improving blood flow awareness, the aim is to lower the chance of leaks, which can lead to longer hospital stays and other health problems. This is a large study to see if this technique should become a standard part of surgery.
At a glance
What is this study about?
When someone has surgery for bowel cancer, the surgeon often needs to remove a section of the bowel. Afterwards, the remaining healthy ends are stitched or stapled back together. This join is called an 'anastomosis'. A common and serious problem that can happen after this type of surgery is an 'anastomotic leak'. This means the join doesn't heal properly and can leak, causing infection and other health issues. This complication can lead to longer recovery times, more time in hospital, and can sometimes be life-threatening.
This study, called FLUOCOL-1, is looking at a technique that might help prevent these leaks. During surgery, a special dye called indocyanine green (ICG) is injected into the patient. This dye, which is safe, glows under a special near-infrared light, allowing surgeons to see the blood flow in the bowel very clearly. The idea is that by having a clearer picture of the blood supply to the joined bowel ends, surgeons can make sure the join is in the best possible position and has plenty of blood, which is crucial for healing.
The aim of this large, important study is to find out if using this dye, called fluorescence angiography, really does reduce the number of anastomotic leaks after bowel cancer surgery. If the results show that it successful, it could become a standard part of how these surgeries are done, helping more patients recover better and faster after their operation. It could improve patient safety, reduce healthcare costs, and ultimately help patients get back to their normal lives sooner.
Key takeaways
- This study aims to improve safety during bowel cancer surgery.
- It uses a special dye to help surgeons see blood flow in the bowel.
- The goal is to reduce the risk of a serious complication called an 'anastomotic leak'.
- Participation involves being randomly assigned to one of two treatment groups.
- The study will check your recovery for 90 days after surgery.
- If successful, this technique could become standard practice for bowel surgery.
Who may be eligible?
This study is looking for adults aged 18 or over who are having surgery for certain types of bowel cancer. Specifically, it's for people having an operation on the left side of their colon or for a high rectal cancer, where the surgeon plans to join the bowel ends back together inside the tummy. You would need to be well enough for planned surgery and be part of the French social security system.
There are several reasons why you wouldn't be able to join. For example, if you need emergency surgery, or if your cancer requires a very extensive operation that removes a lot of the bowel. You also can't participate if you have a recurring cancer, or if you've had similar bowel surgery before. People with certain other medical conditions like inflammatory bowel disease, or a known allergy to the indocyanine dye, cannot take part.
Also, if you are pregnant, under guardianship, or if you simply prefer not to participate or cannot give informed consent, you won't be included. The study is designed for a specific group of patients to ensure the results are clear and helpful for future cancer treatment.
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 planned surgery for left-sided or high rectal cancer?
- Will your surgeon be joining parts of your bowel back together inside your tummy?
- Are you not having emergency surgery or very extensive bowel removal?
- Do you not have certain other specific medical conditions or previous surgeries?
- Are you not pregnant and can you give informed consent?
What does participation involve?
If you join this study, you'll be randomly put into one of two groups. One group will have the standard bowel cancer surgery, and the other group will have the same surgery but also receive the special indocyanine green dye injection during the operation to help the surgeons see blood flow. The dye is given once during the operation. After your surgery, the research team will keep track of your health for 90 days (about three months) to see if any complications, like an anastomotic leak, occur. Your regular follow-up appointments and check-ups during this time will be part of the study monitoring. There are no extra tests or medications beyond your normal care, except for the dye if you are in that particular group.
Potential risks and benefits
Locations (32)
- Centre Hospitalier Universitaire Amiens-PicardieVerified postcodeAmiens, France· Recruiting
- CH AnnecyVerified postcodeAnnecy, France· Recruiting
- Centre Hospitalier Universitaire de BesançonVerified postcodeBesançon, France· Recruiting
- Centre Hospitalier Bourgoin-JallieuVerified postcodeBourgoin, France· Recruiting
- University Hospital of DijonVerified postcodeDijon, France· Recruiting
- Centre Georges François LeclercVerified postcodeDijon, France· Recruiting
- Centre Hospitalier Universitaire de GrenobleVerified postcodeLa Tronche, France· Recruiting
- Centre Hospitalier Universitaire de LilleVerified postcodeLille, France· Recruiting
- Centre lyonnais de chirurgie digestiveVerified postcodeLyon, France· Recruiting
- Centre Hospitalier Lyon-SudVerified postcodeLyon, France· Recruiting
- Hôpiatl EuropéenVerified postcodeMarseille, France· Recruiting
- Hôpital La TimoneVerified postcodeMarseille, France· Recruiting
Common questions
What is an 'anastomotic leak'?
It's when the joined parts of your bowel don't heal properly after surgery and can leak, causing problems like infection.
What is indocyanine green (ICG) dye?
It's a special, safe dye that helps surgeons see blood flow clearly under a special light during your operation.
Will I definitely get the dye if I join the study?
No, you'll be randomly assigned to either receive the dye during surgery or have standard surgery without the dye.
How long will I be followed in the study?
The study will check on your recovery and any complications for 90 days after your surgery.
Will this study affect my usual cancer treatment?
No, your main cancer surgery and treatment will remain the same. This study looks at an additional technique during the operation itself.
How to find out more
Zaher Lakkis, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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