Bowel Urgency in Inflammatory Bowel Disease

NCT ID: NCT06069167

Last Updated: 2024-03-26

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

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-12

Study Completion Date

2024-03-22

Brief Summary

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Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.

A meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Collection of data related to bowel urgency

Data will be extracted from the patient's medical record and patients will be interviewed to collect data specific to the research

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged at least 18 years old
* Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
* Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria

* Person unable to comply with study procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paris IBD Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut des MICI

Neuilly-sur-Seine, , France

Site Status

Countries

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France

Other Identifiers

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PIBDC-2023-01

Identifier Type: -

Identifier Source: org_study_id

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