Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576402
• Other study ID #: 333
• Status: Recruiting
• Start date: May 2, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: December 2022
• Source: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Contact: Juan S Lasa, MD
• Phone: 541140848182
• Email: juanselasa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Inflammatory bowel diseases comprise two distinctive entities: Crohn's disease and ulcerative colitis. During the last decade, endoscopic assessment of inflammation has become relevant since it is a prognostic factor. As a consequence, therapeutic targets now contemplate mucosal healing as part of the goals to be achieved. Endoscopic scores for Crohn's disease and ulcerative colitis have been developed to objectively assess the mucosal inflammatory activity. Although they may have some limitations, these scores have been widely accepted in referral centers, especially since they have been adopted as standard evaluation in inflammatory bowel disease clinical trials . However, their use in the setting of endoscopic practice outside centers with a high volume or with less experience in clinical trials is not known.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 20, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who underwent colonoscopy for the evaluation of mucosal inflammatory activity

• Patients with an established diagnosis of either Crohn's disease or ulcerative colitis

Exclusion Criteria:

• Sigmoidoscopies performed in ulcerative colitis for the assessment of mucosal inflammatory activity

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• colonoscopy
endoscopic exploration of colonic mucosa to evaluate inflammatory activity in patients with either Crohn's disease or ulcerative colitis

Locations

Country	Name	City	State
Argentina	CEMIC	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic score report	Proportion of colonoscopy reports among inflammatory bowel disease patients which include an endoscopic score to assess inflammatory activity	January 2018-October 2022