Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD
Roma, 00168, Italy
NCT Number: NCT06603298
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Roma, 00168, Italy
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Evaluation of the Efficacy and Safety of Endoscopic Dilatation Combined With Biological Therapy Therapy for the Treatment of Intestinal Stenosis in Patients With Crohn's Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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