RecruitingNAINTERVENTIONAL

Study of the Kono-S Anastomosis Versus the Side-to-side Functional End Anastomosis

This research is looking at two different surgical ways to join parts of the bowel after removing a diseased section in people with Crohn's disease. One method is called Kono-S and the other is the standard side-to-side approach. The main goal is to find out which type of surgery stops Crohn's disease from flaring up again in the long run. They will check on patients over many years to see how well each surgery works, not just by looking at the bowel, but also by understanding how it affects patients' daily lives, general health, and quality of life. This is a multi-centre study, meaning it's happening in several hospitals to get a good understanding of the results.

At a glance

Status

Recruiting

Phase

Sponsor

Weill Medical College of Cornell University

Enrolment target

600

Start

12 Mar 2014

Estimated completion

31 Dec 2036

Crohn's Disease

What is this study about?

When you have Crohn's disease, sometimes a part of your bowel can become very inflamed and damaged, needing to be removed by surgery. After taking out the unhealthy section, surgeons need to join the remaining healthy parts back together. This study is all about comparing two different ways surgeons can do this joining, called an 'anastomosis.'

One method is the standard 'side-to-side' join that has been used for a while. The other is a newer method called the 'Kono-S' join. The researchers believe the Kono-S method might be better at preventing Crohn's disease from coming back in that area after surgery. This is really important because if the disease returns, it can cause more problems and sometimes even lead to more surgery. By comparing these two methods, the study hopes to find out which one offers the best long-term results for people with Crohn's disease.

This isn't just about what they see on scans or in tests; the study also wants to understand how these surgeries affect your life. They'll be looking at things like your general health, how well you can work, and your feelings about your illness over many years. This will help doctors make better decisions about which surgery to recommend in the future, ultimately improving care for people living with Crohn's disease.

Key takeaways

Compares two surgical techniques (Kono-S vs. side-to-side) for Crohn's disease.
Aims to find which surgery best prevents the disease from returning.
Includes long-term follow-up for up to 10 years after surgery.
Examines how surgery affects patients' daily lives and quality of life.
Involves a random assignment to one of the two surgical groups.
Aims to improve future surgical care and outcomes for Crohn's patients.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older with Crohn's disease that affects your small bowel (ileitis) or both your small and large bowel (ileocolitis). You must be preparing for your first surgery to remove a diseased section of your bowel.

There are certain reasons why you might not be able to join. For example, if you've already had surgery for Crohn's disease in the past, or if you're pregnant. Also, if your Crohn's disease is very widespread and affects many parts of your bowel that aren't next to each other, making the surgery more complicated than what this study is looking at, you wouldn't be eligible. The hospital team would assess your specific situation to see if the study is right for you.

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?
Do you have Crohn's disease affecting your small bowel (ileitis) or small and large bowel (ileocolitis)?
Is this your first surgery to remove a diseased section of your bowel?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive one of the two types of surgery: either the Kono-S method or the standard side-to-side method. This decision will be made by chance, like flipping a coin. After your surgery, the research team will keep in close contact with you for a very long time – up to 10 years. They will monitor your health and how your Crohn's disease is doing through regular check-ups, which may include special scans or procedures to look inside your bowel. You'll also be asked to complete questionnaires about your quality of life, how you feel about your illness, and how your condition affects your daily activities each year. The team will also track your medications, any hospital readmissions, and overall well-being throughout this period.

Potential risks and benefits

Taking part in this study could potentially help improve future treatment for Crohn's disease by identifying the most effective surgical method. While there are no guarantees, you might personally benefit from close monitoring of your condition. As with any surgery, there are risks, and the specific risks of each surgical technique would be discussed in detail by your surgeon. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (15)

Massachusetts General Hospital
Verified postcode
Boston, United States· Terminated
Weill Cornell Medical College
Verified postcode
New York, United States· Recruiting
University of Oklahoma
Verified postcode
Oklahoma City, United States· Terminated
Baylor Scott & White Research Institute
Verified postcode
Dallas, United States· Terminated
Baylor College of Medicine
Verified postcode
Houston, United States· Terminated
University of Washington Medical Center
Verified postcode
Seattle, United States· Terminated
University Clinics Gasthuisberg Herestraat
Verified postcode
Leuven, Belgium· Recruiting
Helsinki University Hospital
Verified postcode
Helsinki, Finland· Terminated
Universitätsklinik Würzburg
Verified postcode
Würzburg, Germany· Recruiting
Charité Campus Benjamin Franklin
Verified postcode
Berlin, Germany· Recruiting
Theresien Hospital and St. Hedwigs Clinic gGmbH
Verified postcode
Mannheim, Germany· Recruiting
Azienda Ospedaliero-Universitaria Careggi
Verified postcode
Florence, Italy· Recruiting

Common questions

What is an 'anastomosis'?

It's the medical term for joining two ends of your bowel together after a diseased section has been removed during surgery.

Why is this study important for Crohn's disease?

It aims to find the best surgical way to prevent Crohn's disease from coming back after an operation, which can help patients live healthier lives.

Will I get to choose which surgery I have?

No, if you join, you will be randomly assigned to one of the two surgery types, like drawing lots, to ensure a fair comparison.

How long will I be followed up if I join?

The study will follow your health and progress for a long time, up to 10 years after your surgery.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your ongoing medical care.

How to find out more

Koianka Trencheva, Dr.PH,BSN,MS

kivanova@med.cornell.edu 646-962-2342 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.