Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

Sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno (Other)

Overall Status

Recruiting

CT.gov ID

NCT05576402

Collaborator

(none)

1,500

Enrollment

Location

9.7

Anticipated Duration (Months)

155.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Procedure: colonoscopy

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Endoscopic Scoring System Utilization for Inflammatory Bowel Disease Activity Assessment

Actual Study Start Date :

May 2, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Feb 20, 2023

Outcome Measures

Primary Outcome Measures

Endoscopic score report [January 2018-October 2022]
Proportion of colonoscopy reports among inflammatory bowel disease patients which include an endoscopic score to assess inflammatory activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEMIC	Buenos Aires		Argentina	1425

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juan Lasa, Principal investigator, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

ClinicalTrials.gov Identifier:

NCT05576402

Other Study ID Numbers:

First Posted:

Oct 12, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Dec 28, 2022