Methods/design
CD stenosis, inflammatory bowel disease
SECONDARY, RECRUITMENT, INFLAMMATORY BOWEL DISEASE
The ENDOCIR trial is a multicentre, open-label, randomized clinical trial with two parallel groups, without masking and with a 1:1 allocation ratio. Forty patients with de novo CD stenosis will be recruited from 15 hospitals in Spain and will be randomly assigned for endoscopic or surgical treatment. All Spanish tertiary and secondary centres with expertise in the management of inflammatory bowel disease were invited to participate through national meetings and e-mails. Finally, 15 of these centres agreed to participate in the study.Central ethical approval of the study protocol has been confirmed by the Comitè Ètic d’Investigació Clínica (CEIC) of the Hospital Universitari Mútua Terrassa. The recruitment at other centres will not begin until local ethical approval has been obtained. A checklist with the recommendations for interventional trials (SPIRIT) is attached as an additional file (see Additional file EndoCir flow chart