Actively Recruiting

Age: 18Years +
All Genders
ID05016700

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

Led by Evangelisches Klinikum Köln Weyertal gGmbH · Updated on 2025-03-10

500

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

E

Evangelisches Klinikum Köln Weyertal gGmbH

Lead Sponsor

U

University of Cologne

Collaborating Sponsor

AI-Summary

What this Trial Is About

Constipation and defecation disorders affect a significant portion of the population, especially those over 65 years old, leading to major quality of life restrictions and high healthcare costs. The causes of these disorders are complex and not fully understood. This research investigates neuropathological changes, such as the loss of ganglion cell clusters and changes in nerve supply in the intestinal wall, which may be linked to inflammatory and autoimmune processes possibly triggered by infections. The study involves analyzing intestinal tissue samples from patients with bowel evacuation disorders who have undergone surgery or rectal full-wall biopsies when surgery is not indicated. Researchers correlate these neuropathological findings with clinical symptoms and scores. Blood samples are also collected to explore diagnostic options for identifying patients with nerve cell disruptions in the bowel. Participants will be assessed through clinical scoring systems, questionnaires about their symptom history and anxiety levels, and neuropathological examination of tissue samples. The study aims to better understand the mechanisms behind chronic intestinal emptying disorders by linking clinical data with tissue changes over a 10-year period. This includes monitoring psychological health and autoimmune markers to improve diagnosis and treatment approaches.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obstructive defecation disorder scheduled for surgery
  • Must be able to undergo surgery
  • At least 18 years of age
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • No defecation disorder
  • No surgery needed
  • Unable to undergo surgery
  • Younger than or equal to 18 years
  • No consent given

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Duration of hospital stay post-surgery

Participants undergo surgery for their bowel evacuation disorder and receive immediate post-operative care.

1 surgical procedure and immediate post-operative assessments

Neuropathological and Clinical Correlation

Duration - Up to 10 years

Neuropathological examination of intestinal wall samples is performed and correlated with clinical symptoms over time.

Periodic clinical assessments and questionnaires

Trial Site Locations

Total: 1 location

1

Evangelisches Klinikum Koeln Weyertal

Cologne, North Rhine-Westphalia, Germany, 50931

Actively Recruiting

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Research Team

C

Claudia L Rudroff, MD

J

Joshy Madukkakuzhy

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Colonic neuropathological aspects in patients with intractable constipation due to obstructed defecation.

Gabrio Bassotti, Vincenzo Villanacci, Riccardo Nascimbeni...

https://pubmed.ncbi.nlm.nih.gov/17277762

The role of glial cells and apoptosis of enteric neurones in the neuropathology of intractable slow transit constipation.

G Bassotti, V Villanacci, C A Maurer...

https://pubmed.ncbi.nlm.nih.gov/16041063

Diagnostic use of endoscopic full-thickness wall resection (eFTR)-a novel minimally invasive technique for colonic tissue sampling in patients with severe gastrointestinal motility disorders.

P V Valli, D Pohl, M Fried...

https://pubmed.ncbi.nlm.nih.gov/28681569

Pathogenic mechanisms of postinfectious functional gastrointestinal disorders: results 3 years after gastroenteritis.

Fermín Mearin, Antonia Perelló, Agustin Balboa...

https://pubmed.ncbi.nlm.nih.gov/19711225

Enteric Murine Ganglionitis Induced by Autoimmune CD8 T Cells Mimics Human Gastrointestinal Dysmotility.

Monica Sanchez-Ruiz, Anna Brunn, Manuel Montesinos-Rongen...

https://pubmed.ncbi.nlm.nih.gov/30593823