Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Procedure: colonoscopy

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Juan S Lasa, MD; Phone Number: 541140848182; Email: juanselasa@gmail.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Recruiting
    • Cemic
    • Contact: Juan S Lasa, MD; Phone Number: 541140848182; Email: drjuanslasa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients who have already received a diagnosis of either Crohn's disease or ulcerative colitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
• Investigators: Principal Investigator: Juan S Lasa, MD, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): February 20, 2023

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No