An Epidemiological Study of the Incidence of Inflammatory Bowel Disease in Spain

NCT02686892 | Completed

• 1 other identifier: GIS-2015-INCIDENCIA
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 16

Brief Summary

This is a prospective, observational, multicenter, population-based incidence cohort study which will enroll cases of IBD (CD, UC, or indeterminate colitis) diagnosed in adults over 1 year in Spain. In addition, each incident case that gave his/her informed consent, will be followed up for 12 months to determine changes in phenotype or disease location, the need for immunosuppressive and biologic treatments, and the need for hospital admissions and surgery during the first year after diagnosis.

Conditions

Inflammatory Bowel Disease

Keywords

Inflamatory bowel disease; Crohns disease; ulcerative colitis; incidence; epidemiology

Outcome Measures

Primary Outcomes (1)

• Number of participants with the incidence of inflammatory bowel disease in Spain

  1 year

Secondary Outcomes (4)

• Number of patients with incidece of inflammatory bowel disease in diferent regions of the spanish territory

  1 year

• Characteristics of patients at diagnosis of inflammatory bowel disease

  1 year

• Resourses used in the first year after diagnosis.

  1 year

• Delay from onset of symptoms to diagnosis of the disease

  1 year

Study Arms (2)

Group

Spanish territory population of 46,439,864 inhabitants

Cohort

Incident cases diagnosed with IBD over 12 months in the Spanish territory

Eligibility Criteria

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

Study Population

This is a descriptive observational study in which the whole Spanish population will be considered and which will include all incident cases of inflammatory bowel disease occurring in a year.

You may qualify if:

• Patients over 18 years of age diagnosed with IBD.
• Diagnosis of IBD according to European Crohns and Colitis Organisation (ECCO) criteria.
• The patient must belong to the health area of one of the participating center

You may not qualify if:

• Patients who do not accept to participate in the study

Sponsors & Collaborators

• Javier P. Gisbert: lead
• Grupo Español de trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU): collaborator

Study Sites (16)

Hospital Universitario Reina Sofía

Córdoba, Andalusia, Spain

Location

Hospital Clínico Universitario 'Lozano Blesa'

Zaragoza, Aragon, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Location

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Location

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, Canary Islands, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario de Burgos

Burgos, Castille and León, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, Castille-La Mancha, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, Extremadura, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Location

Hospital San Pedro

Logroño, La Rioja, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Galdakao -Usansolo

Usansolo, Vizcaya, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, Spain

Location

Hospital Universitari La Fe

Valencia, Spain

Location

Related Publications (28)

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MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Javier P Gisbert, MD PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 22, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 28, 2023
• Last Updated: March 1, 2023

Record last verified: 2021-08

Locations

ES (16)