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Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

NCT ID: NCT05576402

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-02

Study Completion Date

2023-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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colonoscopy

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

Intervention Type PROCEDURE

Other Intervention Names

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endoscopic score assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER

Sponsor Role lead

Responsible Party

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Juan Lasa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan S Lasa, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Locations

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CEMIC

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Juan S Lasa, MD

Role: CONTACT

Phone: 541140848182

Email: [email protected]

Facility Contacts

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Juan S Lasa, MD

Role: primary

Other Identifiers

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333

Identifier Type: -

Identifier Source: org_study_id