An observational study in Tracheal Stenosis, sponsored by University of Modena and Reggio Emilia. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by University of Modena and Reggio Emilia · Observational
This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
37 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's enrollment of 66 is below the median of 78 across 12 observational studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →University of Modena and Reggio Emilia is the lead sponsor of 61 studies on the registry; 16 are open to participants now.
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We collected clinical, endoscopic and radiological data of patients with benign tracheal stenosis admitted in two operative Units of the University Hospital of Modena (Italy): The Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B) from November 2012 to November 2017
Exclusion Criteria:
Patients with tracheal stenosis treated with stent placement via rigid bronchoscopy.
Procedure: Stent placement
Patients with tracheal stenosis treated with balloon dilatation via laryngoscope.
All interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed.
Re-stenosis rate over time
Patients were defined as cured if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.
Time frame: 36 months
No study locations are listed for this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Modena and Reggio Emilia