BACKGROUND: Crohn's disease (CD) is a chronic, relapsing and remitting inflammatory bowel disease that can be associated with significant bowel damage and disability. The Lémann Index (LI) is a validated tool for measuring cumulative bowel damage in CD patients through a comprehensive assessment of stricturing, penetrating and surgical lesions. However, prospective studies evaluating bowel damage progression in recently diagnosed CD patients remain limited. OBJECTIVES: To characterise the absolute and longitudinal variations in bowel damage progression, as measured by the LI, in a cohort of recently diagnosed CD patients, and to assess its association with relevant disease features, including disease phenotype, treatment strategies, biomarkers and disability. DESIGN: Study protocol for the Crohn's Disease Cohort Study (CROCO Study), a multicentre, European, prospective cohort study. METHODS AND ANALYSIS: Patients with recently diagnosed CD (within the previous 12 months) will be enrolled and followed up for 5 years. Patients will receive standard-of-care treatment determined by the practising gastroenterologist. Morphological assessments to measure the LI and to evaluate bowel damage progression will be performed at years 1, 3 and 5 after the diagnosis. Disability will be assessed annually using the Inflammatory Bowel Disease - Disability Index (IBD-DI). The primary outcome will be the absolute LI at year 3 following diagnosis. Predictors of bowel damage progression and the association between bowel damage and disability will be analysed. DISCUSSION: The CROCO study represents a unique multicentre cohort of recently diagnosed CD patients, designed to advance the understanding of CD's natural history and evolution. It will facilitate the development of composite scores for predicting bowel damage progression and provide valuable tools for designing future disease-modification trials. TRIAL REGISTRATION: NCT05420233.

Copenhagen Center for Inflammatory Bowel Disease in Children Adolescents and Adults Copenhagen University Hospital Amager and Hvidovre Hvidovre Denmark

Department of Clinical Medicine Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

Department of Gastroenterology Algomed Policlinic Timisoara Romania

Department of Gastroenterology Hospital Álvaro Cunqueiro Vigo Spain

Department of Gastroenterology Hospital da Luz de Lisboa Avenida Lusíada 100 1500 650 Lisboa Portugal

Department of Gastroenterology Hospital Garcia de Orta Almada Portugal

Department of Gastroenterology Hospital Universitario de Galdakao Biobizkaia Health Research Institute Galdakao Spain

Department of Gastroenterology Mater Dei Hospital Msida Malta

Department of Gastroenterology Mount Sinai Hospital New York NY USA

Department of Gastroenterology Slagelse Hospital Slagelse Denmark

Department of Hepato Gastroenterology CHU Amiens Picardie Hôpital Sud Amiens France

Department of Hepatogastroenterology Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of IBD St Mark's National Bowel Hospital London UK

Department of Metabolism Digestion and Reproduction Imperial College London London UK

Division of Gastroenterology Hospital Beatriz Ângelo Loures Portugal

Division of Gastroenterology Hospital da Luz Lisboa Portugal

ECSTRRA Team Institute of Research Saint Louis UMR 1342 Inserm Université Paris Cité Paris France

Gastroenterology and Hepatology Department American Gastroenterology Center Strovolos Cyprus

Gastrounit Medical Division Copenhagen University Hospital Amager and Hvidovre Hvidovre Denmark

Hepato Gastroenterology and Digestive Oncology University Hospital CHU of Liège Liège Belgium

Hospital da Luz Learning Health Luz Saúde Lisboa Portugal

IBD Clinical and Research Clinic ISCARE a s Prague Czech Republic

IBD Research Unit Department of Gastroenterology Hull University Teaching Hospitals Hull UK

IBD Unit CHU Clermont Ferrand Clermont Ferrand France

Inflammatory Bowel Diseases Unit Gastroenterology Department Hospital Clínic of Barcelona CIBERehd Institut D'Investigacions Biomèdiques August Pi 1 Sunyer Barcelona Spain

Institute of Pharmacology 1st Faculty of Medicine Charles University Prague Czech Republic

Instituto Português de Oncologia Lisboa Portugal

Univ Lille Inserm CHU Lille U1286 INFINITE Institute for Translational Research in Inflammation F 59000 Lille France

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NCT05420233