NCT07303673
Completed
Not Applicable
Coblation Assisted Dilatation Versus Modified Maddern Procedure in Subglottic and Cervical Tracheal Stenosis: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Airway diameter
Overview
Brief Summary
This study compares the effectiveness of Coblation-assisted endoscopic airway dilatation with the modified Maddern procedure-which involves endoscopic excision of scar tissue followed by buccal mucosal grafting-in patients with subglottic and/or upper tracheal stenosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All consecutive patients with (grade II, III) subglottic and/or upper tracheal stenosis according to Myer-Cotton grading system
- •all age groups (children and adults)
Exclusion Criteria
- •Patients with cervical spine diseases where an extended position during the procedure could be problematic.
- •Previous neck or oral cavity irradiation.
- •chronic uncontrolled debilitating diseases that might interfere with the healing process e.g. (diabetes mellitus, renal failure, decompensated liver diseases).
Outcomes
Primary Outcomes
Airway diameter
Time Frame: 3, 6, and 12 weeks
assessment of the diameter of the airway after the procedure by endoscopic examination
Secondary Outcomes
- subjective evaluation of breathing(3, 6, and 12 months)
Investigators
Study Sites (1)
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