RecruitingOBSERVATIONAL

Neuropathological Changes of the Intestinal Wall in Patients With Bowel Evacuation Disorders

This study investigates severe constipation and bowel emptying difficulties, which affect many people and significantly impact their quality of life. Even after trying common treatments, some individuals still struggle. Researchers are examining nerve patterns in bowel tissue from patients undergoing surgery for these problems. They are specifically looking at changes in nerve cells and pathways within the bowel wall, and also analysing blood samples. Early findings suggest inflammation might play a role in these nerve changes, potentially linked to past infections. By understanding these underlying causes, the study aims to pave the way for brand new, more effective treatments that directly address the root of the problem, rather than just managing symptoms.

At a glance

Status

Recruiting

Sponsor

Evangelisches Klinikum Köln Weyertal gGmbH

Enrolment target

500

Start

20 Mar 2019

Estimated completion

31 Dec 2033

Defecation Disorder Neuropathology Autoimmune Diseases

What is this study about?

This study is trying to understand why some people experience ongoing difficulties with constipation and emptying their bowels. These problems, sometimes called 'defecation disorders,' can be really upsetting and affect everyday life. They are quite common, especially in older adults.

Usually, doctors first suggest lifestyle changes like diet adjustments, along with medicines to help bowel movements. However, for some people, these treatments don't fully work. In such cases, if surgery becomes necessary for their bowel problems, doctors can take a small piece of bowel tissue. This study looks very closely at these tissue samples, and also at blood samples, to examine the tiny nerve cells and networks within the bowel wall. Researchers noticed that in people with these severe bowel emptying issues, there can be fewer nerve cells or changes in how these nerves are arranged.

The idea is that if we can figure out exactly what’s causing these nerve changes – maybe inflammation, or even a past infection – we can develop much better treatments. Instead of just helping with symptoms, these new treatments could tackle the root cause of the problem, offering real relief and a better quality of life for those affected. This research is a step towards finding those innovative solutions.

Key takeaways

This study investigates the causes of severe, long-term bowel emptying problems.
It examines nerve changes in bowel tissue and blood samples.
The goal is to understand why these problems happen, not to test new treatments directly.
Participation involves providing a blood sample and using tissue from pre-planned surgery.
This research hopes to lead to new, more targeted treatments in the future.

Who may be eligible?

This study is for adults aged 18 or over. You might be able to take part if you have long-standing problems with emptying your bowels (sometimes called an 'obstructive defecation disorder') and your doctors have decided that surgery is the best treatment option for you.

It's important that you are fit enough to have surgery. The doctors will also need your clear permission to take part, which is called informed consent.

You cannot join the study if you don't have this specific bowel emptying problem, if you don't need surgery for it, or if you are under 18 years old. Also, if you're not able to give your consent, you wouldn't be able to participate.

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.

Do you have ongoing problems with emptying your bowels that are severe?
Has your doctor recommended surgery for this bowel condition?
Are you 18 years old or older?
Are you able to give your clear permission to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve providing a blood sample. This is done to look for specific markers that might give clues about your condition. The main part of the study involves looking at a piece of bowel tissue. This tissue would be collected during the surgery you are already scheduled to have for your bowel condition. So, you wouldn't undergo any extra procedures solely for the study. Researchers will then closely examine this tissue and your blood samples to understand the changes in nerve cells, but this won't require any additional effort from you after your surgery. There are no extra visits or medications involved specifically for this research.

Potential risks and benefits

The potential benefits of taking part are that the information gathered from your samples could help researchers understand bowel emptying problems better, potentially leading to new and effective treatments for many people in the future. There are no additional direct risks to you beyond those associated with your planned surgery and a standard blood test. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Evangelisches Klinikum Koeln Weyertal
Verified postcode
Cologne, Germany· Recruiting

Common questions

What kind of bowel problems is this study focusing on?

It's looking at severe, long-term constipation and difficulty emptying bowels, especially when other treatments haven't worked well.

Will I have to have an extra operation for this study?

No, the study will use a piece of bowel tissue from an operation you're already having for your condition.

What will researchers do with my blood sample?

They'll look for certain markers that might help explain the changes happening in your bowel's nerve cells.

Does taking part mean I get a new treatment?

No, this study is about understanding the causes, not testing a new treatment. However, it aims to help develop new treatments for the future.

Can I change my mind about participating?

Yes, you can decide to stop participating at any time without it affecting your medical care.

How to find out more

Claudia L Rudroff, MD

claudia@rudroff.com +49221479 Official trial record

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