Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
This study is looking into the best way to remove large, flat growths (polyps) from the bowel. Doctors sometimes remove these polyps using a method called Endoscopic Mucosal Resection (EMR). This study wants to find out if closing the area where the polyp was removed, or leaving it open, affects how many problems patients experience afterwards. Problems could include bleeding or infection. Researchers will also check if the polyps grow back. The aim is to see if closing the area after removing the polyp leads to fewer complications than not closing it. They hope to improve safety and care for patients needing this procedure.
At a glance
What is this study about?
When doctors find a large, flat growth (polyp) in your bowel, they often remove it using a procedure called Endoscopic Mucosal Resection, or EMR. This is done with a special camera and tools inserted into the bowel. After removing the polyp, there's a small area left behind. Sometimes doctors close this area up, and sometimes they leave it to heal naturally.
This study wants to compare these two approaches. They want to see if closing the area helps prevent problems like bleeding or infection, or if leaving it open is just as safe. They will also be checking to see if the polyps grow back in either group. The main goal is to find the safest way to remove these polyps and help patients recover well, with fewer complications.
By understanding which method works best, doctors can improve future care for people undergoing this common procedure. This is important because removing these polyps early can prevent them from potentially developing into bowel cancer.
Key takeaways
- The study compares closing a wound after polyp removal versus leaving it open.
- It focuses on large, flat polyps in the bowel.
- Aims to find out which method causes fewer complications.
- Involves follow-up phone calls and two colonoscopies over 18 months.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years or older, and have a large, flat growth (polyp) in your bowel that your doctor plans to remove using a procedure called EMR. You’ll also need to understand the study and agree to take part by signing a consent form.
There are certain reasons why you might not be able to join. For example, if you have certain bowel conditions like inflammatory bowel disease (Crohn's disease or ulcerative colitis), or if your general health isn't very good. Also, if you have problems with your blood clotting, or if your polyp is a specific type (pedunculated, meaning it has a stalk), you wouldn't be able to take part.
Other reasons for not being able to join include if doctors suspect the growth might already be a deep cancer, if it's too close to the appendix or end of the small bowel, or if you are pregnant. The study is also not for emergency procedures; your colonoscopy needs to be planned.
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 a large (20mm or more), flat bowel polyp removed by EMR?
- Do you not have inflammatory bowel disease (like Crohn's or ulcerative colitis)?
- Is your general health good (not severely ill)?
- Are you not pregnant?
- Is your planned colonoscopy not an emergency?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of two groups by chance, like flipping a coin. One group will have the area where the polyp was removed closed up, and the other group will have it left open. Both groups will have their polyp removed in the usual way.
After your procedure, a research assistant will contact you between 2 and 6 weeks later to check how you're feeling and if you've had any problems. They will also look at your medical records for any emergency hospital visits related to your procedure. You will also need to have two follow-up colonoscopies, one around 6 months and another around 18 months after your initial procedure, to check the removal site and make sure no new polyps have grown.
Potential risks and benefits
Locations (1)
- Centre Hospitalier de l'Université de MontréalVerified postcodeMontreal, Canada· Recruiting
Common questions
What is an EMR?
EMR stands for Endoscopic Mucosal Resection. It's a procedure where doctors remove growths (polyps) from the lining of your bowel using a special camera and tools.
What is a 'large non-pedunculated polyp'?
This refers to bowel growths that are quite big (20mm or larger) and flat, rather than having a stalk like a mushroom.
Will I know which treatment group I'm in?
Yes, this is an 'open-label' study, meaning both you and your doctor will know whether the closure was performed or not after your procedure.
How long will I be followed in this study?
You will be followed for about 18 months after your initial procedure, with check-up calls and two follow-up colonoscopies.
What if I change my mind about participating?
You have the right to leave the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.
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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