Neuropathological Changes of the Intestinal Wall in Patients With Bowel Evacuation Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEvangelisches Klinikum Köln Weyertal gGmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
obstructive defecation disorder scheduled for surgery
must be able to undergo surgery
> 18 years of age
informed consent
Disqualifiers
no defecation disorder
no surgery needed
unable to undergo surgery
≤ 18 years
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
blood sample
Diagnostic testwe want to identify a diagnostic option to identify patients, who have a neuropathological distraction of their ganglia cells in the bowel
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Neuropathological changes of the intestinal wall in patients with bowel evacuation disorder in correlation to clinical defecation score
Clinical outcome measure by score: Altomare Score (name of initiator) score (minimum 0 to maximum 30 points; higher values mean worse outcome)
Time frame
10 yearsSecondary outcomes
1
Correlation of psychic health and neuropathological changes of the intestinal wall in patients with defecation disorder
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
Time frame
10 years2
Correlation of anxiety scoring and neuropathological changes of the intestinal wall in patients with defecation disorder
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
Time frame
10 years3
Association of pathological findings for autoimmune activation with duration of symptoms according to medical history
Onset of symptoms in correlation to severity and picture of pathological findings in months
Time frame
questionaire at inclusion to study4
Association of pathological findings for autoimmune reaction with an initiating event according to the medical questionaire
Identification of an initiating event to the occurrence of the symptoms
Time frame
questionaire at inclusion to studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Evangelisches Klinikum Köln Weyertal gGmbH
Lead sponsor
University of Cologne
Collaborator
Source ClinicalTrials.gov