RecruitingNAINTERVENTIONAL

KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease

This study is looking at two ways to join the bowel after surgery for Crohn's disease: the 'Kono-S' technique and the 'conventional' (standard) technique. Crohn's disease often comes back after surgery, so doctors are trying to find the best way to reduce this. The Kono-S method is a newer approach that has shown some promising results in preventing Crohn's from returning, especially in the long term. This study will be the first large, multi-centre trial to compare these two methods thoroughly. The main goal is to see which technique leads to fewer recurrences of Crohn's disease after the operation.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

226

Start

01 Mar 2025

Estimated completion

01 Feb 2029

Crohn Disease

What is this study about?

Crohn's disease is a long-term condition that causes inflammation in your digestive system. While medicines can help, many people with Crohn's eventually need surgery to remove parts of their bowel that are severely affected. Unfortunately, surgery isn't a cure, and the disease often comes back, especially where the bowel sections are joined together after the operation. This returning of the disease can cause new symptoms and sometimes means more surgery is needed.

Doctors are always looking for better ways to do this surgery to keep you well for longer. One newer technique is called the 'Kono-S anastomosis'. This is a special way of joining the ends of your bowel together that some studies suggest might reduce the chance of Crohn's coming back. Other studies, however, haven't shown such clear benefits, or they were quite small. This means we need more research to be sure which method is best.

This study, called KOALA, is a big and important step. It's the first large-scale study that will randomly assign people to either receive the Kono-S technique or the standard joining method. By carefully comparing the two, and by making sure the assessments are done independently, we hope to find out if the Kono-S method truly is better at preventing Crohn's disease from returning after surgery. This information will help doctors decide on the best surgical approach for people with Crohn's disease in the future.

Key takeaways

This study compares two surgical techniques for Crohn's disease.
It aims to see if the 'Kono-S' method reduces disease recurrence more than the standard method.
You'll be randomly assigned to one of the two surgery types.
Follow-up will include regular check-ups and a camera test (endoscopy).
The study seeks to improve future surgical care for people with Crohn's disease.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have Crohn's disease. You must be planned to have your first bowel surgery for Crohn's because of strictures (narrowing), fistulas (abnormal connections), abscesses (collections of pus), or because your disease hasn't responded to medication. You also need to be part of the French social security system.

You cannot take part if you've had bowel surgery for Crohn's disease before, or if you can't have a follow-up endoscopy (a camera test inside your bowel) after the operation. Also, if your surgery is an emergency for something like peritonitis (a severe infection), or if you need a temporary stoma as part of your surgery, you won't be able to join. Pregnant patients, or anyone who doesn't want to or can't give their consent, also can't take part.

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 between 18 and 75 years old?
Do you have Crohn's disease?
Is this your first bowel surgery for Crohn's?
Are you planning to have surgery because of narrowing, fistulas, abscesses, or medication not working?
Are you able to have a follow-up camera test after surgery?
Are you NOT pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference will be the type of bowel joining technique your surgeon uses during your operation for Crohn's disease. You'll be randomly assigned to either the Kono-S method or the standard method, meaning you or your doctor won't choose which one you receive.

After your surgery, you'll have regular follow-up appointments and tests, including an endoscopy around 6 months after your operation, and likely further follow-ups for several years. The doctors will be looking closely to see if your Crohn's disease returns. You'll continue with any medications your doctor recommends for your Crohn's disease, as usual. The total duration of your participation in the study will involve several years of follow-up to see the long-term results of the surgery.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a surgical technique that could reduce the chances of your Crohn's disease returning after your operation. However, there's no guarantee, and the standard method is also a proven treatment. As with any surgery, there are risks involved, regardless of the technique used, such as infection or issues with the bowel healing. These will be fully explained by your medical team. You are completely free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (15)

CHu de Besançon
Verified postcode
Besançon, France· Recruiting
CHU de Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHU de Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
CHU de Lille Hopital Claude Huriez
Verified postcode
Lille, France· Not yet recruiting
HCL-Hôpital Lyon Sud
Verified postcode
Lyon, France· Not yet recruiting
AP-HM Hôpital Nord
Verified postcode
Marseille, France· Not yet recruiting
CHU de Nançy
Verified postcode
Nancy, France· Not yet recruiting
CHU de Nantes
Verified postcode
Nantes, France· Not yet recruiting
Ap-HP Hopital St Louis
Verified postcode
Paris, France· Not yet recruiting
AP-HP Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Not yet recruiting
AP-HP Le Kremlin-Bicetre
Verified postcode
Paris, France· Not yet recruiting
AP-HP St Antoine
Verified postcode
Paris, France· Not yet recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system, which can lead to symptoms like tummy pain, diarrhoea, and weight loss.

What is 'recurrence' in Crohn's disease?

Recurrence means the Crohn's disease shows signs of coming back, often at the site of the surgery, after an operation has been done.

What is an anastomosis?

An anastomosis is the surgical joining of two ends of the bowel after a section has been removed.

Will I know which surgery I'm getting?

No, you will be randomly assigned to either the Kono-S technique or the standard technique. Neither you nor your doctor will get to choose.

Are there extra costs for joining the study?

No, there should be no extra costs to you for participating in the study.

How to find out more

Zaher LAKKIS

zlakkis@chu-besancon.fr +33381218988 Official trial record

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