An observational study in Crohn Disease, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
All patients with Crohn\'s disease, already undergoing biological therapy for the treatment of clinically significant intestinal stenosis and/or already undergoing endoscopic balloon dilatation during the period January 2016 - June 2024 will be enrolled.
All patients meeting all inclusion criteria and no exclusion criteria will be offered participation in the study upon presentation of the information form and signing of the informed consent for participation in the study. Each patient will be assigned a progressive identification number (ID).
All clinical data will be recorded for all patients:
All available data on stenosis characteristics will be recorded:
All data related to the endoscopic procedure will also be recorded:
The occurrence of episodes of intestinal sub-occlusion or occlusion will be recorded, the introduction of steroid therapy and the need for surgery. Where available radiological and endoscopic re-evaluation data will be recorded.
Any changes in treatment and any adverse events, defined as any adverse event, will also be recorded. as any adverse event without a necessary causal relationship with the endoscopic procedure and the concomitant ongoing biological therapy.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's planned enrollment of 182 is close to the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.
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patients with Crohn\'s disease
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Exclusion Criteria:
It includes patients with Crohn's disease who were only treated with biological therapy for clinically significant intestinal stenosis. These patients underwent drug treatment without any endoscopic procedure.
It includes patients who received both endoscopic dilatation (ED) with a balloon and biological therapy. This cohort underwent combined treatment for intestinal stenosis, integrating mechanical and pharmacological intervention.
Proportion of patients with transitable colonoscopy at 12 months assessed by endoscopic and radiological documentation
Measurement of the percentage of patients with Crohn's disease and intestinal stenosis who obtain a transitable colonoscopy after 12 months of follow-up, comparing two interventions: single biological therapy vs. endoscopic dilatation combined with biological therapy. Transitability of the colonoscopy will be determined by the ability of the colonoscope to completely pass through the stenosis as documented in the endoscopic and/or radiological reports. Data will be aggregated as the proportion of patients with transitable colonoscopy in the total number of patients in each treatment group.
Time frame: 12 months
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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