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

March 7, 2025 updated by: Claudia Rudroff, Evangelisches Klinikum Köln Weyertal gGmbH

Correlation of Clinical Symptoms With Neuromorphological Changes of the Colorectal Wall in Patients With a Bowel Evacuation Disorder

Constipation and defecation disorders affect about 15% of the European population and of those up to 30% of the patients over 65 years of age. For those affected, this is associated with major restrictions in quality of life and high health care costs .

The underlying causes of constipation and defecation are complex and only partially understood.

Intestinal (full wall) resections taken in clinical practice from these patients when conservative therapy has been exhausted show rarefaction of ganglion cell nests in the myenteric plexus and submucosal plexus as well as changes in cholinergic innervation.

Initial histopathological investigations suggest an inflammatory genesis of this rarefaction of ganglion cell nests, which will be further characterised/investigated in the context of this study on the basis of further histopathological and serological investigations. This may lead to novel therapeutic approaches that can causally treat the symptoms of those affected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intestinal transit disorders (constipation/obstipation) and/or defecation disorders (expulsion disorders) are widespread symptoms in our culture, which, depending on their severity, can become a disease. Epidemiological studies show that up to 30% of the population over the age of 65 is affected. The suffering of those affected is usually very high.

The patients are usually treated conservatively at first. The focus is on lifestyle changes, dietary adjustments and medication to support bowel movements. If the symptoms persist despite consistent conservative therapy, additional diagnostics such as laboratory tests, sonography and colonoscopy are performed.

Further diagnostic steps include anal manometry, defecography and colon transit time.

From 2015 onwards, the systematic neuropathological examination of whole-wall samples was performed on the bowel specimen of patients who were surgically treated for defecation disorders. In addition, in individual cases in which no bowel resection was indicated, rectal full-wall samples were taken to confirm the diagnosis and indication for sacral nerve stimulation (SNS) and examined neuropathologically in the same way. The intestinal wall was examined for ganglion cell nests in the myenteric plexus and the submucosal plexus in order to identify the pathophysiological cause of the transport disorder.

The analysis showed rarefaction of the ganglion cell nests in the myenteric plexus and the submucosal plexus, as well as both a change in the cholinergic innervation and changes that suggest an autoimmune initiated process.

Increasing evidence links gastroenteritic germs with chronic intestinal motility disorders, so that a Campylobacter or Yersinia infection could well be the trigger for the observed neuropathological changes.

The aim of the study is to analyse the pathomechanism of chronic intestinal emptying disorders. Neuropathological findings on the plexus of the intestinal wall specimen are correlated to clinical findings measured by clinical scores in order to identify a diagnostic pattern.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Northrhine Westphalia
      • Cologne, Northrhine Westphalia, Germany, 50931

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with severe defecation disorders, both in terms of colonic transit disorder and obstructive defecation disorder, and combinations of both, who have been managed conservatively and require a full-wall bowel biopsy or bowel resection for medical indication.

Description

Inclusion Criteria:

  • obstructive defecation disorder scheduled for surgery
  • must be able to undergo surgery
  • > 18 years of age
  • informed consent

Exclusion Criteria:

  • no defecation disorder
  • no surgery needed
  • unable to undergo surgery
  • ≤ 18 years
  • no consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathological changes of the intestinal wall in patients with bowel evacuation disorder in correlation to clinical defecation score
Time Frame: 10 years
Clinical outcome measure by score: Altomare Score (name of initiator) score (minimum 0 to maximum 30 points; higher values mean worse outcome)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of psychic health and neuropathological changes of the intestinal wall in patients with defecation disorder
Time Frame: 10 years
Changes in QoL and relief from depressive symptoms after surgery measured by clinical psysic health questionnaire (PHQ 9) ; minimum 0 to maximum 27 points; higher scores mean worse outcome
10 years
Correlation of anxiety scoring and neuropathological changes of the intestinal wall in patients with defecation disorder
Time Frame: 10 years
Changes in anxiety symptoms after surgery measured by clinical general anxiety score (GAD 7); minimum 0 to maximum 21 points; higher scores mean worse outcome
10 years
Association of pathological findings for autoimmune activation with duration of symptoms according to medical history
Time Frame: questionaire at inclusion to study
Onset of symptoms in correlation to severity and picture of pathological findings in months
questionaire at inclusion to study
Association of pathological findings for autoimmune reaction with an initiating event according to the medical questionaire
Time Frame: questionaire at inclusion to study
Identification of an initiating event to the occurrence of the symptoms
questionaire at inclusion to study
Correlation of abdominal discomforting symptoms and neuropathological changes of the intestinal wall in patients with bowel evacuation disorder
Time Frame: 10 years
Clinical outcome measure rectal toxicity score (minimum 0 to maximum 32 points; higher scores mean worse outcome)
10 years
Correlation of neuropathological changes of the intestinal wall in patients with bowel evacuation disorder and clinical defecation insufficiency (incontinence)
Time Frame: 10 years
Clinical outcome measure by score: Wexner (name of initiator) incontinence score (minimum 0 to maximum 20 points; higher scores mean worse outcome)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evangelisches Klinikum Köln Weyertal gGmbH

Collaborators

University of Cologne

Investigators

  • Principal Investigator: Claudia Rudroff, MD, Claudia Rudroff, MD PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

July 24, 2021

First Submitted That Met QC Criteria

August 20, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVKKoeln

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of data all data will be uploaded to clinical trials

IPD Sharing Time Frame

now

IPD Sharing Access Criteria

open

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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