RecruitingNAINTERVENTIONAL

Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

Crohn's disease often requires surgery, but it can come back even after an operation. This study is investigating a new surgical technique for Crohn's disease, specifically for people who are already taking certain biologic medications, like infliximab or adalimumab. The surgery involves removing a bit more tissue around the affected part of the bowel, which some research suggests could help prevent the disease from returning. Researchers want to check if this new method is just as safe as the standard surgery, and if it could reduce the chance of Crohn's showing up again inside the bowel within six months after the operation. Most participants will have their regular check-ups, with no added visits or procedures.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

Start

15 Sep 2025

Estimated completion

01 Mar 2028

Crohn Disease

What is this study about?

If you have Crohn's disease, you might need surgery at some point, as it's quite common. Unfortunately, even after surgery, the disease can sometimes come back, leading to more symptoms. There's a part of your body called the mesentery, which is tissue that holds your intestines in place. In Crohn's disease, this mesentery can also be affected, and some doctors believe that removing a bit more of this tissue during surgery might help keep the disease away for longer. This new surgical approach is called an extended mesenteric resection.

This study wants to find out if this newer surgery is as safe as the standard surgery and if it helps people stay healthier for longer without the disease returning. The researchers are particularly interested in patients who are taking specific types of medications called 'biotherapies' (also known as biologics), such as infliximab or adalimumab, as these treatments play a big role in managing Crohn's disease.

The main goal is to see if this modified surgery can reduce the chance of Crohn's disease coming back within six months after the operation, and whether it's just as safe as the usual surgery. By doing this research, doctors hope to offer better surgical options for people with Crohn's disease in the future, helping them to live more comfortably with fewer disease flare-ups.

Key takeaways

This study is about a new surgery for Crohn’s disease.
It aims to see if removing a bit more tissue during surgery (called 'mesentery-embedding') is safe and reduces disease recurrence.
It's for people with Crohn's having bowel surgery who are also on biologic medications (like infliximab).
The study hopes to find better ways to keep Crohn's disease from coming back after surgery.
Participation would mean you have the new surgical procedure but no extra tests beyond your routine care.

Who may be eligible?

To join this study, you need to be an adult with Crohn's disease that has been officially diagnosed by a doctor. You must be having a type of surgery called an ileocolic resection (this can be your first or a repeat operation). It's also important that you are currently taking a biologic medication for your Crohn's, such as infliximab, adalimumab, or similar treatments.

There are certain reasons you might not be able to join. For example, if you're already participating in another medical study that involves an experimental treatment, or if you have serious heart problems that make surgery very risky. This study is not for women who are pregnant or breastfeeding. Also, if you need a different type of medical treatment for your Crohn's than the specific biologics mentioned, you wouldn't be able to join.

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.

I have Crohn's disease that has been confirmed by a doctor.
I am having surgery to remove part of my bowel (ileocolic resection).
I am currently taking a biologic medication for my Crohn's (e.g., infliximab, adalimumab, vedolizumab, ustekinumab, risankizumab).
I am not pregnant or breastfeeding.
I am not currently in another medical study for a new treatment.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have the specific type of surgery being investigated, called an ileocolic resection with extended mesenteric resection. After your surgery, doctors will regularly check your bowel using a procedure called an endoscopy to see if the Crohn's disease has returned. These checks are typically part of your usual care after Crohn's surgery. You will continue to take your existing biologic medication as prescribed by your doctor. The study will monitor your progress and health for six months after the surgery to compare the outcomes with those who had standard surgery. There are no additional visits or procedures required beyond what you would normally have for your ongoing Crohn's care and post-surgery follow-up.

Potential risks and benefits

Every surgery carries some risks, and this study aims to confirm that the new surgical approach is no more risky than the standard operation for Crohn's disease. Potential benefits include the possibility that this new technique could reduce the chance of your Crohn's disease coming back after surgery, potentially meaning fewer symptoms and better long-term health. However, there's no guarantee of benefit. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

CHU de Montpellier Hôpital St Eloi
Verified postcode
Montpellier, France· Recruiting
CHU de Nîmes
Verified postcode
Nîmes, France· Recruiting

Common questions

What is 'biotherapy'?

Biotherapy, or biologics, are medications for Crohn's disease that target specific parts of your immune system to help reduce inflammation.

What is an 'ileocolic resection'?

This is a type of surgery where a section of your small intestine (ileum) and large intestine (colon) is removed if it's severely affected by Crohn's disease.

What does 'mesentery-embedding surgery' mean?

It means the surgeon removes a bit more of the fatty tissue (mesentery) that surrounds the diseased part of your bowel, in addition to the bowel itself.

Will I have extra appointments if I join?

No, you shouldn't have any extra appointments. The study uses information from your regular follow-up and endoscopy checks after surgery.

Can I still join if I'm on a different Crohn's medication?

To be part of this particular study, you need to be taking specific biologic medications like infliximab or adalimumab.

How to find out more

Martin BERTRAND

martin.bertrand@chu-nimes.fr 04 66 68 31 43 Official trial record

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