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NCT Number: NCT05016700

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

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.

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Key information

Conditions

Defecation Disorder Autoimmune Diseases Immune System Diseases Neuropathology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Diagnostic Test

we want to identify a diagnostic option to identify patients, who have a neuropathological distraction of their ganglia cells in the bowel

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia L Rudroff, MD

CONTACT

[email protected]

+49221479 ext. 5110

Joshy Madukkakuzhy

CONTACT

[email protected]

+49221479 ext. 5121

Sponsors and collaborators

Lead sponsor

Evangelisches Klinikum Köln Weyertal gGmbH

Other

Collaborators

  • University of Cologne

Registry information

Official study title

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

Acronym: Constipation

Important dates

Study start
2019
Primary completion
2030
Study completion
2033
First posted
Aug 23, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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