Investigating changes in the intestinal wall related to bowel evacuation disorders
Correlation of Clinical Symptoms With Neuromorphological Changes of the Colorectal Wall in Patients With a Bowel Evacuation Disorder
This study is looking at the changes in the intestines of people with bowel problems to see if it can help find new treatments for constipation and related issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Evangelisches Klinikum Köln Weyertal gGmbH Academic / other |
| Locations | 1 site (Cologne, North Rhine-Westphalia) |
| Trial ID | NCT05016700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the neuropathological changes in the intestinal wall of patients suffering from defecation disorders. It focuses on patients who are scheduled for surgery due to obstructive defecation disorders, examining the ganglion cell nests in the myenteric and submucosal plexus through histopathological and serological investigations. The study seeks to understand the inflammatory processes that may contribute to these disorders, potentially leading to new therapeutic approaches. By analyzing bowel specimens, the research aims to uncover the underlying causes of constipation and defecation disorders, which affect a significant portion of the population, especially the elderly.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have obstructive defecation disorders and are scheduled for surgical intervention.
Not a fit: Patients who do not have a defecation disorder or do not require surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to novel treatments that address the root causes of bowel evacuation disorders, improving quality of life for affected patients.
How similar studies have performed: While this study builds on previous findings regarding neuropathological changes in bowel disorders, it employs a specific focus on inflammatory processes that may not have been extensively explored in prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cologne, North Rhine-Westphalia
- Evangelisches Klinikum Koeln Weyertal — Cologne, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Claudia Rudroff, MD — Claudia Rudroff, MD PhD
- Study coordinator: Claudia L Rudroff, MD
- Email: claudia@rudroff.com
- Phone: +49221479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.