Endoscopic Scoring System Utilization in Inflammatory Bowel Disease

NCT05576402 | Unknown

• 1 other identifier: 333
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

colonoscopy PROCEDURE

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

Also known as: endoscopic score assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno: lead

Study Sites (1)

CEMIC

Buenos Aires, 1425, Argentina

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Juan S Lasa, MD

  Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan S Lasa, MD

CONTACT

541140848182; juanselasa@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: May 2, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 20, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)