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Clinical Trial NCT05016700 (Constipation) for Defecation Disorder, Neuropathology, Autoimmune Diseases is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Neuropathological Changes of the Intestinal Wall in Patients With Bowel Evacuation Disorders (Constipation) 500 Novel Treatment

Recruiting
Clinical Trial NCT05016700 (Constipation) is an observational study for Defecation Disorder, Neuropathology, Autoimmune Diseases that is recruiting. It started on March 20, 2019 with plans to enroll 500 participants. Led by Evangelisches Klinikum Köln Weyertal gGmbH, it is expected to complete by December 31, 2033. The latest data from ClinicalTrials.gov was last updated on March 10, 2025.
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 th...

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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...

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Official Title

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

Conditions
Defecation DisorderNeuropathologyAutoimmune Diseases
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • Constipation
  • EVKKoeln
NCT ID Number
NCT05016700
Start Date (Actual)
2019-03-20
Last Update Posted
2025-03-10
Completion Date (Estimated)
2033-12-31
Enrollment (Estimated)
500
Study Type
Observational
Status
Recruiting
Keywords
Neuropathology
Defecation disorder
Autoimmune disease
Hypoganglionosis
Autoimmune ganglionitis
Neurological bowel disorder
Colon surgery
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
blood sample
we want to identify a diagnostic option to identify patients, who have a neuropathological distraction of their ganglia cells in the bowel
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
10 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
10 years
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
10 years
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
questionaire at inclusion to study
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
questionaire at inclusion to study
Correlation of abdominal discomforting symptoms and neuropathological changes of the intestinal wall in patients with bowel evacuation disorder
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)
Clinical outcome measure by score: Wexner (name of initiator) incontinence score (minimum 0 to maximum 20 points; higher scores mean worse outcome)
10 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • obstructive defecation disorder scheduled for surgery
  • must be able to undergo surgery
  • > 18 years of age
  • informed consent

  • no defecation disorder
  • no surgery needed
  • unable to undergo surgery
  • ≤ 18 years
  • no consent
Evangelisches Klinikum Köln Weyertal gGmbH logoEvangelisches Klinikum Köln Weyertal gGmbH
University of Cologne logoUniversity of Cologne78 active studies to explore
Study Responsible Party
Claudia Rudroff, Principal Investigator, Head of the Department of Visceral Surgery and Functional Surgery of the lower GI Tract, Evangelisches Klinikum Köln Weyertal gGmbH
Study Central Contact
Contact: Claudia L Rudroff, MD, +49221479, [email protected]
Contact: Joshy Madukkakuzhy, +49221479, [email protected]
1 Study Locations in 1 Countries

North Rhine-Westphalia

Evangelisches Klinikum Koeln Weyertal, Cologne, North Rhine-Westphalia, 50931, Germany
Claudia L Rudroff, PhD MD, Contact, +49-221-479, [email protected]
Joshy Madukkakuzhy, Contact, +49-221-479, [email protected]
Recruiting