Oxygenation in Vascular Lesions of the Colon

Not Applicable

Recruiting

• Conditions: Vascular Lesion
• Interventions: Other: Oxygen saturation

• Registration Number: NCT06230731
• Lead Sponsor: University of Chicago

Brief Summary

The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.

Detailed Description

The etiology of acquired vascular abnormalities of the large bowel (i.e. angiodysplasia, AVM, hemangiomas of the cecum. etc.) are unknown. These lesions typical appear as ectatic, dilated, and tortuous blood vessels within the submucosa and mucosa of the GI tract. In some patients they are the cause of acute large volume bleeding or a slower chronic bleed that manifests as chronic iron deficiency anemia. These lesions are more common in older individuals and those with underlying cardiac, pulmonary, and renal disease. As such, it is hypothesized that these lesions may result from chronic hypoxia. This study aims to evaluate oxygenation of the colon in people with acquired vascular abnormalities in the proximal colon compared to healthy controls.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Study Start: 2024-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2027-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Undergo standard of care colonoscopy
• People with a history of vascular lesions of the colon
• People with healthy colon
• 18 - 89 years of age

Exclusion Criteria

• Age < 18 years
• Age > 90 years
• People with ulcerations in at ascending colon opposite the ileocecal valve
• Previous colon surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Oxygen saturation	People with healthy colon
Vascular abnormality group	Oxygen saturation	People with acquired vascular abnormalities in the proximal colon

Primary Outcome Measures

Name	Time	Method
Quantitative analysis of colonic oxygen saturation levels	baseline-12 months	Colonic oxygen saturation levels will be compared between patients with vascular lesions of the colon and healthy controls.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States