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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05016700
Acronym
Constipation
Enrollment
100
Registered
2021-08-23
Start date
2019-03-20
Completion date
2026-08-01
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Defecation Disorder, Neuropathology

Keywords

Neuropathology, Defecation disorder, Autoimmune disease, Hypoganglionosis, Autoimmune ganglionitis, Neurological bowel disorder, Colon surgery

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTblood sample

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

Sponsors

Evangelisches Klinikum Köln Weyertal gGmbH
Lead SponsorOTHER
University of Cologne
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neuropathological changes of the intestinal wall in patients with bowel evacuation disorder in correlation to clinical defecation score10 yearsClinical outcome measure by score: Altomare Score (name of initiator) score (minimum 0 to maximum 30 points; higher values mean worse outcome)

Secondary

MeasureTime frameDescription
Correlation of psychic health and neuropathological changes of the intestinal wall in patients with defecation disorder10 yearsChanges 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
Correlation of anxiety scoring and neuropathological changes of the intestinal wall in patients with defecation disorder10 yearsChanges in anxiety symptoms after surgery measured by clinical general anxiety score (GAD 7); minimum 0 to maximum 21 points; higher scores mean worse outcome
Association of pathological findings for autoimmune activation with duration of symptoms according to medical historyquestionaire at inclusion to studyOnset of symptoms in correlation to severity and picture of pathological findings in months
Association of pathological findings for autoimmune reaction with an initiating event according to the medical questionairequestionaire at inclusion to studyIdentification of an initiating event to the occurrence of the symptoms
Correlation of abdominal discomforting symptoms and neuropathological changes of the intestinal wall in patients with bowel evacuation disorder10 yearsClinical outcome measure rectal toxicity score (minimum 0 to maximum 32 points; higher scores mean worse outcome)
Correlation of neuropathological changes of the intestinal wall in patients with bowel evacuation disorder and clinical defecation insufficiency (incontinence)10 yearsClinical outcome measure by score: Wexner (name of initiator) incontinence score (minimum 0 to maximum 20 points; higher scores mean worse outcome)

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORClaudia Rudroff, MD

Claudia Rudroff, MD PhD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026